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ACETAZOLAMIDE capsule, extended release


  1. Acetazolamide Extended-release Capsules
  2. Description
  3. Clinical Pharmacology
  4. Indications And Usage
  5. Contraindications
  6. Warnings
  7. Precautions
  8. Adverse Reactions
  9. Overdosage
  10. Dosage And Administration
  11. How Supplied
  12. Packaging Information
  13. Package/label Display Panel Carton 500 Mg
  14. Package/label Display Panel Blister 500 Mg
  15. Spl Unclassified
  16. Package Label.principal Display Panel
  17. Indications And Usage
  18. Dosage And Administration
  19. Package Label.principal Display Panel - 500 Mg
  20. Acetazolamide
  21. Acetazolamide Extended-release Capsules
  22. Principal Display Panel

Acetazolamide Extended-release Capsules 

8240121/1215

Rx Only

Description 

Acetazolamide extended-release capsules are an inhibitor of the enzyme carbonic anhydrase.

Acetazolamide is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide and has the following chemical structure:

Structured product formula for escitazolamide

MW 222.24 C4H6N4O3S2

Each acetazolamide extended-release capsule intended for oral administration contains 500 mg of acetazolamide. In addition, each capsule contains the following inactive ingredients: ammonio methacrylate copolymer dispersion type A and B, FD&C yellow #6, gelatin, microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent.

Clinical Pharmacology 

Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g., some types of glaucoma), in the treatment of certain convulsive disorders (e.g., epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (e.g., cardiac edema).

Acetazolamide is not a mercurial diuretic. Rather, it is a non-bacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic sulfonamides.

Acetazolamide is an enzyme inhibitor that acts specifically on carbonic anhydrase, the enzyme that catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In the eye, this inhibitory action of acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of glaucoma and even in certain non-glaucomatous conditions. Evidence seems to indicate that acetazolamide has utility as an adjuvant in treatment of certain dysfunctions of the central nervous system (e.g., epilepsy). Inhibition of carbonic anhydrase in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The diuretic effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid. The result is renal loss of HCO3 ion, which carries out sodium, water, and potassium. Alkalinization of the urine and promotion of diuresis are thus affected. Alteration in ammonia metabolism occurs due to increased reabsorption of ammonia by the renal tubules as a result of urinary alkalinization.

Acetazolamide extended-release capsules provide prolonged action to inhibit aqueous humor secretion for 18 to 24 hours after each dose, whereas tablets act for only eight to 12 hours. The prolonged continuous effect of acetazolamide permits a reduction in dosage frequency.

Plasma concentrations of acetazolamide peak from three to six hours after administration of acetazolamide extended-release capsules, compared to one to four hours with tablets. Food does not affect bioavailability of acetazolamide extended-release capsules.

Placebo-controlled clinical trials have shown that prophylactic administration of acetazolamide at a dose of 250 mg every eight to 12 hours (or a 500 mg controlled-release capsule once daily) before and during rapid ascent to altitude results in fewer and/or less severe symptoms of acute mountain sickness (AMS) such as headache, nausea, shortness of breath, dizziness, drowsiness, and fatigue. Pulmonary function (e.g., minute ventilation, expired vital capacity, and peak flow) is greater in the acetazolamide treated group, both in subjects with AMS and asymptomatic subjects. The acetazolamide treated climbers also had less difficulty in sleeping.

Indications And Usage 

For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

Contraindications 

Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible.

Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy.

Long-term administration of acetazolamide is contraindicated in patients with chronic non-congestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

Warnings 

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, anaphylaxis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitizations may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this drug.

Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported.

Precautions 

General:

Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paresthesia. Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure diuresis in complete refractory failure.

Information for Patients:

Adverse reactions common to all sulfonamide derivatives may occur: anaphylaxis, fever, rash (including erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia, leukopenia, pancytopenia, and agranulocytosis. Caution is advised for early detection of such reactions and the drug should be discontinued and appropriate therapy instituted.

In patients with pulmonary obstruction or emphysema where alveolar ventilation may be impaired, acetazolamide which may precipitate or aggravate acidosis should be used with caution. Gradual ascent is desirable to try to avoid acute mountain sickness. If rapid ascent is undertaken and acetazolamide is used, it should be noted that such use does not obviate the need for prompt descent if severe forms of high altitude sickness occur, i.e., high altitude pulmonary edema (HAPE) or high altitude cerebral edema.

Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, metabolic acidosis, coma, and death have been reported (see WARNINGS).

Both increases and decreases in blood glucose have been described in patients treated with acetazolamide. This should be taken into consideration in patients with impaired glucose tolerance or diabetes mellitus.

Acetazolamide treatment may cause electrolyte imbalances, including hyponatremia and hypokalemia, as well as metabolic acidosis. Therefore, periodic monitoring of serum electrolytes is recommended. Particular caution is recommended in patients with conditions that are associated with, or predispose a patient to, electrolyte and acid/base imbalances, such as patients with impaired renal function (including elderly patients; see PRECAUTIONS, Geriatric Use), patients with diabetes mellitus, and patients with impaired alveolar ventilation.

Some adverse reactions to acetazolamide, such as drowsiness, fatigue, and myopia, may impair the ability to drive and operate machinery.

Laboratory Tests:

To monitor for hematologic reactions common to all sulfonamides, it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating acetazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is recommended.

Drug Interactions:

Aspirin:

See WARNINGS

Acetazolamide modifies phenytoin metabolism with increased serum levels of phenytoin. This may increase or enhance the occurrence of osteomalacia in some patients receiving chronic phenytoin therapy. Caution is advised in patients receiving chronic concomitant therapy. By decreasing the gastro-intestinal absorption of primidone, acetazolamide may decrease serum concentrations of primidone and its metabolites, with a consequent possible decrease in anticonvulsant effect. Caution is advised when beginning, discontinuing, or changing the dose of acetazolamide in patients receiving primidone.

Because of possible additive effects with other carbonic anhydrase inhibitors, concomitant use is not advisable.

Acetazolamide may increase the effects of other folic acid antagonists.

Acetazolamide decreases urinary excretion of amphetamine and may enhance the magnitude and duration of their effect.

Acetazolamide reduces urinary excretion of quinidine and may enhance its effect.

Acetazolamide may prevent the urinary antiseptic effect of methenamine.

Acetazolamide increases lithium excretion and the lithium may be decreased.

Acetazolamide and sodium bicarbonate used concurrently increases the risk of renal calculus formation.

Acetazolamide may elevate cyclosporine levels.

Drug/laboratory test interactions:

Sulfonamides may give false negative or decreased values for urinary phenolsulfonphthalein and phenol red elimination values for urinary protein, serum non-protein, and serum uric acid. Acetazolamide may produce an increased level of crystals in the urine.

Acetazolamide interferes with the HPLC method of assay for theophylline. Interference with the theophylline assay by acetazolamide depends on the solvent used in the extraction; acetazolamide may not interfere with other assay methods for theophylline.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate the carcinogenic potential of acetazolamide has not been conducted. In a bacterial mutagenicity assay, acetazolamide was not mutagenic when evaluated with and without metabolic activation.

The drug had no effect on fertility when administered in the diet to male and female rats at a daily intake of up to 4 times the recommended human dose of 1000 mg in a 50 kg individual.

Pregnancy:

Teratogenic effects:

Pregnancy Category C:

Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters, and rabbits. There are no adequate and well-controlled studies in pregnant women. Acetazolamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Because of the potential for serious adverse reactions in nursing infants from acetazolamide, 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. Acetazolamide should only be used by nursing women if the potential benefit justifies the potential risk to the child.

Pediatric Use:

The safety and effectiveness of acetazolamide extended-release capsules in pediatric patients below the age of 12 years have not been established. Growth retardation has been reported in children receiving long-term therapy, believed secondary to chronic acidosis.

Geriatric Use:

Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

Adverse Reactions 

Body as a whole:

Headache, malaise, fatigue, fever, pain at injection site, flushing, growth retardation in children, flaccid paralysis, anaphylaxis.

Digestive:

Gastrointestinal disturbances such as nausea, vomiting, diarrhea.

Hematological/Lymphatic:

Blood dyscrasias such as aplastic anemia, agranulocytosis, leukopenia, thrombocytopenic purpura, melena.

Hepato-biliary disorders:

Abnormal liver function, cholestatic jaundice, hepatic insufficiency, fulminant hepatic necrosis

Metabolic/Nutritional:

Metabolic acidosis, electrolyte imbalance, including hypokalemia, hyponatremia, osteomalacia with long-term phenytoin therapy, loss of appetite, taste alteration, hyper/hypoglycemia

Nervous:

Drowsiness, paresthesia (including numbness and tingling of extremities and face), depression, excitement, ataxia, confusion, convulsions dizziness

Skin:

Allergic skin reactions including urticaria, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis

Special senses:

Hearing disturbances, tinnitus, transient myopia

Urogenital:

Crystalluria, increased risk of nephrolithiasis with long-term therapy, hematuria, glycosuria, renal failure polyuria

Overdosage 

No specific antidote is known. Treatment should be symptomatic and supportive.

Electrolyte imbalance, development of an acidotic state, and central nervous system effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of bicarbonate.

Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide may be dialyzable. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of renal failure.

Dosage And Administration 

Glaucoma:

The recommended dosage is 1 capsule (500 mg) two times a day. Usually 1 capsule is administered in the morning and 1 capsule in the evening. It may be necessary to adjust the dose, but it has usually been found that dosage in excess of 2 capsules (1 g) does not produce an increased effect. The dosage should be adjusted with careful individual attention both to symptomatology and intraocular tension. In all cases, continuous supervision by a physician is advisable.

In those unusual instances where adequate control is not obtained by the twice-a-day administration of acetazolamide extended-release capsules, the desired control may be established by means of acetazolamide (tablets or parenteral). Use tablets or parenteral in accordance with the more frequent dosage schedules recommended for these dosage forms, such as 250 mg every four hours, or an initial dose of 500 mg followed by 250 mg or 125 mg every four hours, depending on the case in question.

Acute Mountain Sickness:

Dosage is 500 mg to 1000 mg daily, in divided doses using tablets or extended-release capsules as appropriate. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.

How Supplied 

Acetazolamide Extended-Release Capsules, 500 mg are white to off-white pellets filled in empty hard gelatin capsules with orange opaque cap imprinted with "EP" in black ink and white opaque body imprinted with "107" in black ink and are supplied as follows:

NDC 68382-261-01 in bottle of 100 capsules

NDC 68382-261-10 in bottle of 1000 capsules

Storage:

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

Dispense in well-closed containers.

Manufactured by:

Heritage Pharma Labs Inc.

East Brunswick, NJ 08816

Distributed by:

logo

Zydus Pharmaceuticals USA Inc.

Pennington,NJ 08534

51U000000001US02

Revised: 01/2015

Packaging Information 

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Zydus Pharmaceuticals USA Inc. as follows:
(500 mg / 30 UD) NDC 68084-401-21 packaged from NDC 68382-261

Distributed by:
American Health Packaging
Columbus, OH 43217

8240121/1215

Package/label Display Panel Carton 500 Mg 

Acetazolamide Carton 500 mg Carton LabelNDC 68084-401-21

AcetaZOLAMIDE
EXTENDED-RELEASE Capsules

500 mg

30 Capsules (3 x 10)

Each extended-release capsule contains:
AcetaZOLAMIDE ....................................................... 500 mg

Usual Dosage: See package insert for complete
prescribing information.

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

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is from NDC
# 68382-261, Zydus Pharmaceuticals (USA) Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

040121
Rev. 05/2014

Package/label Display Panel Blister 500 Mg 

Acetazolamide Extended-Release Capsule 500 mg Card Print

AcetaZOLAMIDE
EXTENDED-RELEASE Capsule
500 mg

ACETAZOLAMIDE
acetazolamide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-401(NDC:68382-261)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color orange (opaque orange) , white (opaque white) Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code EP;107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-401-21 30 in 1 CARTON 02/15/2010 08/31/2020
1 NDC:68084-401-11 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 ANDA040904 02/15/2010 08/31/2020
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(68084-401)

Revised: 2/2019 American Health Packaging

Spl Unclassified 

Acetazolamide Extended-Release Capsules

Rx only

Package Label.principal Display Panel 

NDC 68382-261-01 in bottle of 100 tablets

Acetazolamide Extended-release Capsules, 500 mg

Rx only

100 tablets

ZYDUS

Acezolamide ER Capsules, 500 mg
ACETAZOLAMIDE
acetazolamide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-261
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B (UNII: 161H3B14U2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE (OPAQUE ORANGE) , WHITE (OPAQUE WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 25mm
Flavor Imprint Code EP;107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68382-261-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:68382-261-10 1000 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 ANDA040904 12/15/2008
Labeler - Zydus Pharmaceuticals USA Inc. (156861945)
Registrant - Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Business Operations
HERITAGE PHARMA LABS, INC 189630168 analysis(68382-261) , label(68382-261) , manufacture(68382-261) , pack(68382-261)

Revised: 4/2015 Zydus Pharmaceuticals USA Inc.

Indications And Usage 

For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

Dosage And Administration 

Glaucoma:

The recommended dosage is 1 capsule (500 mg) two times a day. Usually 1 capsule is administered in the morning and 1 capsule in the evening. It may be necessary to adjust the dose, but it has usually been found that dosage in excess of 2 capsules (1 g) does not produce an increased effect. The dosage should be adjusted with careful individual attention both to symptomatology and intraocular tension. In all cases, continuous supervision by a physician is advisable.


In those unusual instances where adequate control is not obtained by the twice-a-day administration of acetazolamide extended-release capsules, the desired control may be established by means of acetazolamide (tablets or parenteral). Use tablets or parenteral in accordance with the more frequent dosage schedules recommended for these dosage forms, such as 250 mg every four hours, or an initial dose of 500 mg followed by 250 mg or 125 mg every four hours, depending on the case in question.


Acute Mountain Sickness: Dosage is 500 mg to 1000 mg daily, in divided doses using tablets or extended-release capsules as appropriate. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.

Package Label.principal Display Panel - 500 Mg 

NDC 62332-349-31
acetaZOLAMIDE
Extended-Release
Capsules
500 mg
Rx only
100 Capsules
Alembic


100 Capsules
ACETAZOLAMIDE
acetazolamide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-349
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
Product Characteristics
Color ORANGE (orange opaque cap and body) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code A;247
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62332-349-31 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/20/2019
2 NDC:62332-349-91 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/20/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210423 02/20/2019
Labeler - Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Business Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE(62332-349)

Revised: 2/2019 Alembic Pharmaceuticals Inc.

Acetazolamide 

Label Image
ACETAZOLAMIDE
acetazolamide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3132(NDC:23155-120)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)
TALC (UNII: 7SEV7J4R1U)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
SHELLAC (UNII: 46N107B71O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
Product Characteristics
Color GREEN (light green) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code HP120
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-3132-0 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090779 09/24/2012
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-3132) , REPACK(50090-3132)

Revised: 5/2018 A-S Medication Solutions

Acetazolamide Extended-release Capsules 

Rx only

Revised December 2015

Principal Display Panel 

acetazolamide 500 mg, 100 Capsules

NDC 29033-030-01

Acetazolamide Extended-release Capsules, 500 mg

100 Capsules

Rx only

This package is not for household use.
USUAL DOSAGE: See Package Insert.

Store at controlled room temperature 20 C to 25 C (68 F to 77 F) [see USP Controlled Room Temperature].

Dispense in well-closed containers.

ACETAZOLAMIDE
acetazolamide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29033-030
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OLEIC ACID (UNII: 2UMI9U37CP)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AMMONIA (UNII: 5138Q19F1X)
TALC (UNII: 7SEV7J4R1U)
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code NA;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29033-030-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204691 03/30/2016
Labeler - Nostrum Laboratories, Inc. (791142354)
Establishment
Name Address ID/FEI Business Operations
Nostrum Laboratories, Inc. 791142354 MANUFACTURE(29033-030) , ANALYSIS(29033-030) , pack(29033-030) , label(29033-030)

Revised: 2/2019 Nostrum Laboratories, Inc.



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