facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

BETHANECHOL CHLORIDE tablet


  1. No Title 1572549268
  2. No Title 1572550142
  3. No Title 1572550442
  4. No Title 1572553529
  5. Bethanechol Chloride Tablets, Usp5 Mg, 10 Mg, 25 Mg And 50 Mg
  6. Description
  7. Clinical Pharmacology
  8. Indications And Usage
  9. Contraindications
  10. Precautions
  11. Adverse Reactions
  12. Overdosage
  13. Dosage And Administration
  14. How Supplied
  15. Principal Display Panel - 5 Mg Tablet Bottle Label
  16. Principal Display Panel - 10 Mg Tablet Bottle Label
  17. Principal Display Panel - 25 Mg Tablet Bottle Label
  18. Principal Display Panel - 50 Mg Tablet Bottle Label
  19. No Title 1572449690
  20. Indications & Usage
  21. Dosage & Administration
  22. Package Label.principal Display Panel
  23. No Title 1572449831
  24. Bethanechol Chloride 10mg Tablet
  25. Description
  26. Clinical Pharmacology
  27. Indications And Usage
  28. Contraindications
  29. Precautions
  30. Adverse Reactions
  31. Overdosage
  32. Dosage And Administration
  33. How Supplied
  34. Package Label.principal Display Panel 5 Mg
  35. Package Label.principal Display Panel 10 Mg
  36. Package Label.principal Display Panel 25 Mg
  37. Package Label.principal Display Panel 50 Mg
  38. Package Label.principal Display Panel
  39. No Title 1572452466
  40. Description:
  41. Clinical Pharmacology:
  42. Indications And Usage:
  43. Contraindications:
  44. Precautions:
  45. Adverse Reactions:
  46. Overdosage:
  47. Dosage And Administration:
  48. How Supplied:
  49. Principal Display Panel
  50. Package/label Display Panel
  51. No Title 1572452649
  52. Packaging Information
  53. Package/label Display Panel Carton 10 Mg
  54. Package/label Display Panel Blister 10 Mg
  55. Package/label Display Panel Carton 25 Mg
  56. Package/label Display Panel Blister 25 Mg
  57. Description
  58. Principal Display Panel 5 Mg Container Label
  59. Principal Display Panel 10 Mg Container Label
  60. Principal Display Panel 25 Mg Container Label
  61. Principal Display Panel 50 Mg Container Label
  62. Product Informationbethanechol Chloride Tablets, Usp
  63. References
  64. Package/label Display Panel

No Title 1572549268 

Full Prescribing Information

No Title 1572550142 

Bethanechol Chloride

Tablets, USP

Rx only

No Title 1572550442 

Full Prescribing Information

No Title 1572553529 

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42141

Manufactured by:

Amneal Pharmaceuticals
Paterson, New Jersey 07504

Rx Only

Rev.04-2011

Bethanechol Chloride Tablets, Usp5 Mg, 10 Mg, 25 Mg And 50 Mg  

Rx only

Description  

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl) oxy]-N, N,N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN202 and its structural formula is:

38055a93-figure-01


It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The 25 mg and 50 mg tablets also contain D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake.

Clinical Pharmacology  

Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the Gl and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does oral administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Indications And Usage  

Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications  

Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Precautions  

General: In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients: Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions: Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions  

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating Respiratory: bronchial constriction, asthmatic attacks Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a Whole: malaise; Nervous System: seizures.

Overdosage  

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ( hot feeling ), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Dosage And Administration  

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine [see OVERDOSAGE].

How Supplied  

Bethanechol Chloride Tablets, USP

5 mg - White, round, scored tablets. Debossed AN 571

10 mg - White, round, scored tablets. Debossed AN 572

25 mg - Yellow, round, scored tablets in blistercards of 30. Debossed AN 573

50 mg - Yellow round, scored tablets. Debossed AN 574

This container not intended for household use. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C-30 C (59 F-86 F).
[See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Principal Display Panel - 5 Mg Tablet Bottle Label 

NDC 0832-0510-00

Bethanechol
Chloride
Tablets, USP

5 mg

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label

Principal Display Panel - 10 Mg Tablet Bottle Label 

NDC 0832-0511-00

Bethanechol
Chloride
Tablets, USP

10 mg

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

Principal Display Panel - 25 Mg Tablet Bottle Label 

NDC 0832-0512-00

Bethanechol
Chloride
Tablets, USP

25 mg

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

Principal Display Panel - 50 Mg Tablet Bottle Label 

NDC 0832-0513-00

Bethanechol
Chloride
Tablets, USP

50 mg

100 Tablets
Rx only

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0510
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code BCL;5;832
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0832-0510-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
2 NDC:0832-0510-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
3 NDC:0832-0510-01 100 in 1 CARTON 01/24/2010
3 NDC:0832-0510-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040633 01/24/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0511
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code BCL;10;832
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0832-0511-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
2 NDC:0832-0511-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
3 NDC:0832-0511-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
4 NDC:0832-0511-01 100 in 1 CARTON 01/24/2010
4 NDC:0832-0511-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040634 01/24/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0512
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code BCL;25;832
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0832-0512-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
2 NDC:0832-0512-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
3 NDC:0832-0512-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
4 NDC:0832-0512-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
5 NDC:0832-0512-01 100 in 1 CARTON 01/24/2010
5 NDC:0832-0512-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040635 01/24/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0832-0513
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bethanechol Chloride (UNII: H4QBZ2LO84) (Bethanechol - UNII:004F72P8F4) Bethanechol Chloride 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
lactose monohydrate (UNII: EWQ57Q8I5X)
magnesium stearate (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code BCL;50;832
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0832-0513-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
2 NDC:0832-0513-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
3 NDC:0832-0513-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2010
4 NDC:0832-0513-01 100 in 1 CARTON 01/24/2010
4 NDC:0832-0513-89 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040636 01/24/2010
Labeler - Upsher-Smith Laboratories, LLC (809088862)
Establishment
Name Address ID/FEI Business Operations
Upsher-Smith Laboratories, LLC 809088862 MANUFACTURE(0832-0510, 0832-0511, 0832-0512, 0832-0513) , LABEL(0832-0510, 0832-0511, 0832-0512, 0832-0513) , PACK(0832-0510, 0832-0511, 0832-0512, 0832-0513)
Establishment
Name Address ID/FEI Business Operations
Upsher-Smith Laboratories, LLC 047251004 ANALYSIS(0832-0510, 0832-0511, 0832-0512, 0832-0513)
Establishment
Name Address ID/FEI Business Operations
Upsher-Smith Laboratories, LLC 079111820 LABEL(0832-0510, 0832-0511, 0832-0512, 0832-0513) , PACK(0832-0510, 0832-0511, 0832-0512, 0832-0513)

Revised: 11/2017 Upsher-Smith Laboratories, LLC

No Title 1572449690 

Full Prescribing Information

Indications & Usage  

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Dosage & Administration  

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

Package Label.principal Display Panel  

Bethanechol Chloride Tabs 25mg

BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-7912(NDC:65162-573)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AN;573
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-7912-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040855 11/21/2007
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-7912) , REPACK(0615-7912)

Revised: 9/2015 NCS HealthCare of KY, Inc dba Vangard Labs

No Title 1572449831 

Full Prescribing Information

Bethanechol Chloride 10mg Tablet 

Label Image
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0846(NDC:65162-572)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AN;572
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71335-0846-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018
2 NDC:71335-0846-2 28 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018
3 NDC:71335-0846-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040855 11/21/2007
Labeler - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0846) , RELABEL(71335-0846)

Revised: 9/2018 Bryant Ranch Prepack

Description 

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN2O2 and its structural formula is:

Image

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: lactose monohydrate, silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and povidone.

Clinical Pharmacology 

Bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the GI and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Indications And Usage 

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications 

Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Precautions 

General

In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients

Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions

Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy

Teratogenic effects: Pregnancy Category C

Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions 

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating; Respiratory: bronchial constriction, asthmatic attacks; Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a Whole: malaise; Nervous System: seizures.

To report SUSPECTED ADVERSE REACTIONS, contact Heritage Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage 

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ("hot feeling"), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Dosage And Administration 

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

How Supplied 

Bethanechol Chloride Tablets USP

5 mg White, round, scored tablets in bottles of 100.

Debossed EP 118 on one side and plain on reverse side.

NDC 23155-676-01 Bottles of 100

10 mg White, round, scored tablets in bottles of 100.

Debossed EP 119 on one side and plain on reverse side.

NDC 23155-677-01 Bottles of 100

25 mg White, round, scored tablets in bottles of 100.

Debossed EP 120 on one side and plain on reverse side.

NDC 23155-678-01 Bottles of 100

50 mg - White, round, scored tablets in bottles of 100.

Debossed EP 121 on one side and plain on reverse side.

NDC 23155-679-01 Bottles of 100

Dispense in a tight container as defined in the USP.

Store at 20 -25 C (68 -77 F) [See USP Controlled Room Temperature].

Distributed by:

Heritage Pharmaceuticals Inc.

East Brunswick, NJ 08816

1.866.901.DRUG (3784)

Image

51U000000298US02

Revised: 01/2019

Package Label.principal Display Panel 5 Mg 

NDC 23155-676-01

Bethanechol Chloride Tablets, USP

5 mg

100 Tablets

Rx only

5 mg label

Package Label.principal Display Panel 10 Mg 

NDC 23155-677-01

Bethanechol Chloride Tablets, USP

10 mg

100 Tablets

Rx only

10 mg label

Package Label.principal Display Panel 25 Mg 

NDC 23155-678-01

Bethanechol Chloride Tablets, USP

25 mg

100 Tablets

Rx only

25 mg label

Package Label.principal Display Panel 50 Mg 

NDC 23155-679-01

Bethanechol Chloride Tablets, USP

50 mg

100 Tablets

Rx only

50 mg label
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-676
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code EP118
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23155-676-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 05/04/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-677
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code EP119
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23155-677-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 05/04/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-678
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code EP120
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23155-678-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 05/04/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-679
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code EP121
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23155-679-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/09/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 05/04/2010
Labeler - Heritage Pharmaceuticals Inc. (780779901)
Registrant - Heritage Pharma Labs, Inc (189630168)
Establishment
Name Address ID/FEI Business Operations
Heritage Pharma Labs, Inc 189630168 ANALYSIS(23155-676, 23155-677, 23155-678, 23155-679) , LABEL(23155-676, 23155-677, 23155-678, 23155-679) , MANUFACTURE(23155-676, 23155-677, 23155-678, 23155-679) , PACK(23155-676, 23155-677, 23155-678, 23155-679)

Revised: 2/2019 Heritage Pharmaceuticals Inc.

Package Label.principal Display Panel 

Bethanechol Chloride Tablets, 10 mg

100 Tablets

Rx only

NDC 64980-161-01

Each Tablet Contains:

Bethanechol Chloride, USP 10 mg

Usual Dosage: See package insert.

Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]

WARNING: KEEP THIS AND ALL THE DRUGS OUT OF THE REACH OF CHILDREN

Dispense in a tight container as defined in the USP.

Manufactured for:

Rising Pharmaceuticals, Inc.

Allendale, NJ 07401

Manufactured by:

Heritage Pharma Labs Inc.

East Brunswick, New Jersey 08816, USA

label-10mg
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-160
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code EP118
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64980-160-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 08/24/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-161
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code EP119
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64980-161-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 04/06/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-162
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code EP120
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64980-162-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 04/06/2010
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-163
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code EP121
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64980-163-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091256 04/06/2010
Labeler - Rising Pharmaceuticals Inc. (041241766)
Registrant - Emcure Pharmaceuticals Limited (916921919)
Establishment
Name Address ID/FEI Business Operations
Heritage Pharma Labs, Inc 189630168 analysis(64980-160, 64980-161, 64980-162, 64980-163) , label(64980-160, 64980-161, 64980-162, 64980-163) , manufacture(64980-160, 64980-161, 64980-162, 64980-163) , pack(64980-160, 64980-161, 64980-162, 64980-163)

Revised: 8/2015 Rising Pharmaceuticals Inc.

No Title 1572452466 

Bethanechol Chloride

Tablets, USP

Rx only

Description: 

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N,-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17CIN2O2 and its structural formula is:

The structural formula of Bethanechol chloride.

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow #10 aluminum lake.

Clinical Pharmacology: 

Bethanechol chloride acts principally be producing the effects of stimulation of the parasympathetic nervous system. It increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. It stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis.

Stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. When spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. Bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine.

Effects on the GI and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. Following oral administration, the usual duration of action of bethanechol is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. Subcutaneous injection produces a more intense action on bladder muscle than does administration of the drug.

Because of the selective action of bethanechol, nicotinic symptoms of chlolinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. Muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. Doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. Therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation.

Bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. The metabolic rate and mode of excretion of the drug have not been elucidated.

A clinical study (Diokno, A.C.; Lapides, J.; Urol 10: 23-24, July 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. Results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. All the oral doses, however, had a longer duration of effect than the subcutaneous dose. Although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

Indications And Usage: 

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Contraindications: 

Hypersensitivity to bethanechol chloride tablets, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism.

Bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Precautions: 

General:

In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients:

Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions:

Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear there in such a fall in the blood pressure.

Carcinogeneis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy: Teratogenic Effects:

Pregnancy Category C. Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions: 

Adverse reactions are rare following oral administration of bethanechol, but are more common following subcutaneous injection. Adverse reactions are more likely to occur when dosage is increased.

The following adverse reactions have been observed: Body as a Whole: malaise; Digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation; Renal: urinary urgency; Nervous System: headache; Cardiovascular: a fall in blood pressure with reflux tachycardia, vasomotor response; Skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating; Respiratory: bronchial constriction, asthmatic attacks; Special Senses: lacrimation, miosis.

Causal Relationship Unknown: The following adverse reactions have been reported, and a causal relationship to therapy with bethanechol has not been established: Body as a whole: malaise; Nervous System: seizures.

Overdosage: 

Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin ( hot feeling ), sweating, nausea, and vomiting.

Atropine Sulfate is a specific antidote. The recommended dose for adults is 0.6 mg. Repeat doses can be given every two hours, according to clinical response. The recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. Subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed.

The oral LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

Dosage And Administration: 

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

How Supplied: 

Bethanechol Chloride Tablets are supplied as follows:

5 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1332 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0515-01.

10 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1340 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0516-01.

25 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1356 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0517-01.

50 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1329 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 10135-0518-01.

This container not intended for household use. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Manufactured by:

Lannett Company, Inc.

Philadelphia, PA 19136

RX Only

Made in the USA

Rev. 2 4/15 LAN

Principal Display Panel 

Bethanechol Chloride Tablets, USP 25mg

Principal Display Panel- Bethanechol Chloride Tablets, USP 25mg

BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-2558(NDC:64679-967)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color YELLOW (light yellow) Score 2 pieces
Shape OVAL (oval) Size 7mm
Flavor Imprint Code W;967
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-2558-39 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040533 09/29/2003
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-2557(NDC:64679-966)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 7mm
Flavor Imprint Code W;966
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-2557-39 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040533 09/29/2003
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-2557, 0615-2558) , REPACK(0615-2557, 0615-2558)

Revised: 10/2012 NCS HealthCare of KY, Inc dba Vangard Labs

Package/label Display Panel 

Bethanechol Chloride Tablets USP 50 mg 100s Label

Bethanechol Chloride Tablets USP 50 mg 100s Label Text

NDC 50111-326-01

Bethanechol
Chloride
Tablets, USP
50 mg

Rx only

100 TABLETS

TEVA

BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-323
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;323
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50111-323-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089095 09/30/1990
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-324
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;324
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50111-324-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088440 09/30/1990
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-325
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;325
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50111-325-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088441 09/30/1990
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-326
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;326
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50111-326-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089096 09/30/1990
Labeler - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2017 Teva Pharmaceuticals USA, Inc.

No Title 1572452649 

Full Prescribing Information

Packaging Information 

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
(10 mg / 100 UD) NDC 68084-365-01 packaged from NDC 65162-572
(25 mg / 100 UD) NDC 68084-704-01 packaged from NDC 65162-573

Distributed by:
American Health Packaging
Columbus, OH 43217

8236501/0519F

Package/label Display Panel Carton 10 Mg 

10 mg Bethanechol Chloride Tablets Carton

NDC 68084- 365-01

Bethanechol
Chloride Tablets, USP

10 mg

100 Tablets (10 10) Rx Only

Each Tablet Contains:
Bethanechol Chloride, USP..............................................10 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20 to 25 C (68 to 77 F); excursions permitted
between 15 to 30 C (59 to 86 F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65162-572, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

036501
0236501/0519OS

Package/label Display Panel Blister 10 Mg 

10 mg Bethanechol Chloride Tablet Blister

Bethanechol
Chloride
Tablet, USP

10 mg

Package/label Display Panel Carton 25 Mg 

25 mg Bethanechol Chloride Tablets Carton

NDC 68084- 704-01

Bethanechol
Chloride Tablets, USP

25 mg

100 Tablets (10 10) Rx Only

Each Tablet Contains:
Bethanechol Chloride, USP............................................. 25 mg

Usual Dosage: See package insert for full prescribing
information.

Store at 20 to 25 C (68 to 77 F); excursions permitted
between 15 to 30 C (59 to 86 F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 65162-573, Amneal Pharmaceuticals LLC.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

070401
0270401/0519OS

Package/label Display Panel Blister 25 Mg 

25 mg Bethanechol Chloride Tablet Blister

Bethanechol
Chloride
Tablet, USP

25 mg

BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-365(NDC:65162-572)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code AN;572
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-365-01 100 in 1 BOX, UNIT-DOSE 02/04/2015
1 NDC:68084-365-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040855 02/04/2015
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-704(NDC:65162-573)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code AN;573
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-704-01 100 in 1 BOX, UNIT-DOSE 02/05/2015
1 NDC:68084-704-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040855 02/05/2015
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(68084-365, 68084-704)

Revised: 6/2019 American Health Packaging

Description 

Bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine.

It is designated chemically as 2-[(aminocarbonyl)oxy]-N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C7H17ClN2O2 and its structural formula is:

molec-struc

It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68.

Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, talc, and magnesium stearate; the 50 mg tablet also contains D&C Yellow No. 10 aluminum lake.

Principal Display Panel 5 Mg Container Label 

NDC 0527-1332-01

Bethanechol
Chloride
Tablets, USP

5 mg

Rx Only

100 TABLETS

Lannett

5 mg bottle label

Principal Display Panel 10 Mg Container Label 

NDC 0527-1340-01

Bethanechol
Chloride
Tablets, USP

10 mg

Rx Only

100 TABLETS

Lannett

10 mg bottle label

Principal Display Panel 25 Mg Container Label 

NDC 0527-1356-01

Bethanechol
Chloride
Tablets, USP

25 mg

Rx Only

100 TABLETS

Lannett

25 mg bottle label

Principal Display Panel 50 Mg Container Label 

NDC 0527-1329-01

Bethanechol
Chloride
Tablets, USP

50 mg

Rx Only

100 TABLETS

Lannett

50 mg bottle label
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1332
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1332
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-1332-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040703 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1340
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1340
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-1340-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040704 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1356
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1356
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-1356-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040678 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1329
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LCI;1329
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0527-1329-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
Labeler - Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Business Operations
Kremers Urban Pharmaceuticals Inc. 006422406 LABEL(0527-1332, 0527-1340, 0527-1356, 0527-1329) , PACK(0527-1332, 0527-1340, 0527-1356, 0527-1329)
Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 002277481 MANUFACTURE(0527-1332, 0527-1340, 0527-1356, 0527-1329)
Establishment
Name Address ID/FEI Business Operations
Lannett Company, Inc. 829757603 ANALYSIS(0527-1332, 0527-1340, 0527-1356, 0527-1329) , MANUFACTURE(0527-1332, 0527-1340, 0527-1356, 0527-1329)

Revised: 4/2017 Lannett Company, Inc.

Product Informationbethanechol Chloride Tablets, Usp 

Rx only

References 

Manufactured by:

Wockhardt Limited

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.050810

Package/label Display Panel  

Bethanechol Chloride Tablets, USP

25 mg

100 Tablets

carton label
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6178(NDC:65162-573)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code AN;573
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-6178-61 100 in 1 CARTON 04/01/2010
1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040855 04/01/2010
Labeler - Major Pharmaceuticals (191427277)

Revised: 4/2019 Major Pharmaceuticals



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com