BACLOFEN tablet

1. No Title 1572546329
2. No Title 1572548632
3. No Title 1572549407
4. No Title 1572553373
5. No Title 1572554236
6. No Title 1572554815
7. No Title 1572555265
8. No Title 1572449247
9. Principal Display Panel - 20 Mg
10. Packaging Information
11. Package/label Display Panel Carton 10 Mg
12. Package/label Display Panel Blister 10 Mg
13. Package/label Display Panel Carton 20 Mg
14. Package/label Display Panel Blister 20 Mg
15. No Title 1572450471
16. Baclofen
17. Description
18. Clinical Pharmacology
19. Indications And Usage
20. Contraindications
21. Warnings
22. Precautions
23. Overdosage
24. Dosage And Administration
25. How Supplied
26. Baclofen Tablet
27. No Title 1572454738
28. No Title 1572454802
29. Principal Dispaly Panel
30. No Title 1572448375
31. Description
32. Clinical Pharmacology
33. Indications And Usage
34. Contraindications
35. Warnings
36. Precautions
37. Adverse Reactions
38. Overdosage
39. Dosage And Administration
40. How Supplied
41. Baclofen
42. Package Label.principal Display Panel
43. Pediatric Use
44. Baclofen 10mg Tablet
45. No Title 1572456393
46. No Title 1572457776
47. Repackaging Information
48. Principal Display Panel - 10mg
49. Principal Display Panel

No Title 1572546329 ⮝

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

8181162
Revised: 09/17
R5

No Title 1572548632 ⮝

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8181162
R10/12-R4

No Title 1572549407 ⮝

Rx only

No Title 1572553373 ⮝

Rx only

No Title 1572554236 ⮝

Rx only

No Title 1572554815 ⮝

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

8181162
R10/12-R4

No Title 1572555265 ⮝

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

8181162
Revised: 09/17
R5

No Title 1572449247 ⮝

Rx only

Principal Display Panel - 20 Mg ⮝

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-158(NDC:0527-1330) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color white (white) Score 2 pieces Shape ROUND (round) Size 9mm Flavor Imprint Code LCI;1330 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42291-158-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2014 2 NDC:42291-158-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2014 03/01/2017

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078220 08/25/2014

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-159(NDC:0527-1337) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color white (white) Score 2 pieces Shape ROUND (round) Size 10mm Flavor Imprint Code LCI;1337 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42291-159-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2014 06/30/2018

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077241 08/25/2014 06/30/2018

Labeler - AvKARE, Inc. (796560394)

Revised: 11/2018 Document Id: 7b089422-e8a7-6d3d-e053-2991aa0a4675 34391-3 Set id: 4ac972eb-80f9-18ce-0bec-65f2327398cd Version: 7 Effective Time: 20181119 AvKARE, Inc.

Packaging Information ⮝

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(10 mg / 100 UD) NDC 68084-855-01 packaged from NDC 0527-1330
(20 mg / 100 UD) NDC 68084-868-01 packaged from NDC 0527-1337

Distributed by:
American Health Packaging
Columbus, OH 43217

8285501/0217

Package/label Display Panel Carton 10 Mg ⮝

NDC 68084- 855-01

Baclofen
Tablets, USP

10 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Baclofen, 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 # 0527-1330, Lannett Company, Inc.

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

085501
0285501/1118

Package/label Display Panel Blister 10 Mg ⮝

Baclofen
Tablet, USP

10 mg

Package/label Display Panel Carton 20 Mg ⮝

NDC 68084- 868-01

Baclofen
Tablets, USP

20 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Baclofen, USP 20 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 # 0527-1337, Lannett Company, Inc.

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

086801
0286801/1118

Package/label Display Panel Blister 20 Mg ⮝

Baclofen
Tablet, USP

20 mg

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-855(NDC:0527-1330) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color white (white) Score 2 pieces Shape ROUND (flat-faced beveled edge) Size 9mm Flavor Imprint Code LCI;1330 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68084-855-01 100 in 1 BOX, UNIT-DOSE 03/04/2015 1 NDC:68084-855-11 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 ANDA077241 03/04/2015

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-868(NDC:0527-1337) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color white (white) Score 2 pieces Shape ROUND (flat-faced beveled edge) Size 10mm Flavor Imprint Code LCI;1337 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68084-868-01 100 in 1 BOX, UNIT-DOSE 03/04/2015 1 NDC:68084-868-11 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 ANDA077241 03/04/2015

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(68084-855, 68084-868)

Revised: 3/2019 Document Id: 840e9d8c-efaf-35d0-e053-2a91aa0a58c3 34391-3 Set id: 049ead3c-93da-4dcf-844b-74700fa3a9c8 Version: 5 Effective Time: 20190314 American Health Packaging

No Title 1572450471 ⮝

Rx only

Baclofen ⮝

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2871(NDC:0527-1337) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics Color WHITE (white) Score 2 pieces Shape ROUND (round) Size 10mm Flavor Imprint Code LCI;1337 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-2871-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2017 2 NDC:50090-2871-1 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2018 3 NDC:50090-2871-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077241 12/01/2005

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-2871) , REPACK(50090-2871)

Revised: 7/2019 Document Id: 44129d60-6632-4e87-b752-a0d9effb220a 34391-3 Set id: d7b7c365-0093-4c98-84b1-e1742ce3a08f Version: 14 Effective Time: 20190725 A-S Medication Solutions

Description  ⮝

Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Its molecular formula is C10H12ClNO2 and its structural formula is:

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform.

Each tablet, for oral administration, contains 10 mg or 20 mg of baclofen, USP. In addition, each tablet contains the following inactive ingredients: Crospovidone, anhydrous lactose, magnesium stearate and povidone.

Clinical Pharmacology  ⮝

The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Indications And Usage  ⮝

Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.

Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen tablets, USP in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Contraindications  ⮝

Hypersensitivity to baclofen.

Warnings  ⮝

a. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

b. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.

c. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

d. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits.

There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions  ⮝

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants.

Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function. In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen. It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen.

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Overdosage  ⮝

Signs and Symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures.

Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Dosage And Administration  ⮝

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).

The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).

How Supplied  ⮝

Product: 17856-1024

NDC: 17856-1024-1 1 TABLET in a POUCH

Baclofen Tablet ⮝

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-1024(NDC:0832-1024) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength crospovidone (UNII: 68401960MK) anhydrous lactose (UNII: 3SY5LH9PMK) magnesium stearate (UNII: 70097M6I30) povidones (UNII: FZ989GH94E)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code BAC;10;832 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-1024-1 100 in 1 CASE 11/29/2016 1 1 in 1 POUCH ; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074584 10/20/2010

Labeler - Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantic Biologicals Corps		047437707	RELABEL(17856-1024) , REPACK(17856-1024)

Revised: 11/2016 Document Id: c033a166-a47c-4971-a9e5-34d8431fd3b0 34391-3 Set id: ada5c3a9-ad1e-4351-aab2-8f93386b7fe4 Version: 2 Effective Time: 20161129 Atlantic Biologicals Corps

No Title 1572454738 ⮝

Rx only

No Title 1572454802 ⮝

Rx only

Principal Dispaly Panel ⮝

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-010(NDC:0603-2406) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code 2265;V Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-010-15 15 in 1 BOTTLE, PLASTIC 2 NDC:33261-010-30 30 in 1 BOTTLE, PLASTIC 3 NDC:33261-010-45 45 in 1 BOTTLE, PLASTIC 4 NDC:33261-010-60 60 in 1 BOTTLE, PLASTIC 5 NDC:33261-010-90 90 in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077156 08/30/2005

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-011(NDC:0603-2407) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape OVAL (capsule-shaped) Size 16mm Flavor Imprint Code 2266;V Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-011-30 30 in 1 BOTTLE, PLASTIC 2 NDC:33261-011-60 60 in 1 BOTTLE, PLASTIC 3 NDC:33261-011-90 90 in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077068 08/30/2005

Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 12/2013 Document Id: c3489764-d9f9-4d2a-ab7f-3c3bfa652af7 34391-3 Set id: b127bc0c-6e3b-4906-ab5f-6992a9775038 Version: 1 Effective Time: 20131212 Aidarex Pharmaceuticals LLC

No Title 1572448375 ⮝

Rx only

Description ⮝

Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below:

Baclofen Tablets, USP 10 mg and 20 mg contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

Clinical Pharmacology ⮝

The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-amino-butyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Indications And Usage ⮝

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.

Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Contraindications ⮝

Hypersensitivity to baclofen.

Warnings ⮝

1. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
2. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
3. Stroke: Baclofen has not significantly benefitted patients with stroke. These patients have also shown poor tolerability to the drug.
4. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions ⮝

Safe use of baclofen in children under age 12 has not been established, and it is, therefore, not recommended for use in children.

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants.

Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen.

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen.

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Adverse Reactions ⮝

The most common is transient drowsiness (10 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 15%), weakness (5 15%) and fatigue (2 4%). Others reported:

Neuropsychiatric: Confusion (1 11%), headache (4 8%), insomnia (2 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.

Cardiovascular: Hypotension (0 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: Nausea (4 12%), constipation (2 6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.

Genitourinary: Urinary frequency (2 6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.

Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

Overdosage ⮝

Signs and symptoms:

Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.

Treatment:

In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Dosage And Administration ⮝

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).

How Supplied ⮝

Product: 50090-1801

NDC: 50090-1801-1 60 TABLET in a BOTTLE

NDC: 50090-1801-2 30 TABLET in a BOTTLE

Baclofen ⮝

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1801(NDC:0603-2407) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape OVAL (capsule-shaped) Size 16mm Flavor Imprint Code 2266;V Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1801-1 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2015 2 NDC:50090-1801-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2015

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077068 08/30/2005

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-1801) , REPACK(50090-1801)

Revised: 8/2018 Document Id: ab7c8b49-329e-4a03-b32f-b47b2b942613 34391-3 Set id: 1f566955-2942-4d9a-a030-fcce4c47fd25 Version: 6 Effective Time: 20180822 A-S Medication Solutions

Package Label.principal Display Panel ⮝

NDC ( 72888-011-00)

1000 Tablets

Baclofen Tablets, USP 20 mg

Rx only

Rubicon Research Private Limited

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-009 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color white (White to off white) Score no score Shape ROUND Size 5mm Flavor Imprint Code 023 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72888-009-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209102 09/13/2019

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-010 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color white (White to off white) Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code 024 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72888-010-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 2 NDC:72888-010-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 3 NDC:72888-010-00 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209102 09/13/2019

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-011 Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics Color white (White to off white) Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 025 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72888-011-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 2 NDC:72888-011-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019 3 NDC:72888-011-00 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209102 09/13/2019

Labeler - Advagen Pharma Limited (051627256)

Registrant - Rubicon Research Private Limited (918629544)

Establishment
Name	Address	ID/FEI	Business Operations
Rubicon Research Private Limited		677604197	manufacture(72888-009, 72888-010, 72888-011) , analysis(72888-009, 72888-010, 72888-011)

Revised: 9/2019 Document Id: 926f8956-6ca2-7542-e053-2995a90aa468 34391-3 Set id: 04dac0f6-cc6c-4959-9bca-a6e4a99690f3 Version: 1 Effective Time: 20190913 Advagen Pharma Limited

Pediatric Use ⮝

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Baclofen 10mg Tablet ⮝

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0206(NDC:16714-071) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, POTATO (UNII: 8I089SAH3T) POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics Color WHITE Score 2 pieces Shape ROUND (FLAT) Size 8mm Flavor Imprint Code N029 Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0206-7 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 2 NDC:71335-0206-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 3 NDC:71335-0206-4 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 4 NDC:71335-0206-5 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 5 NDC:71335-0206-2 120 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 6 NDC:71335-0206-8 140 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 7 NDC:71335-0206-0 112 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 8 NDC:71335-0206-3 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 9 NDC:71335-0206-6 56 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016 10 NDC:71335-0206-9 84 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078504 01/01/2011

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0206) , RELABEL(71335-0206)

Revised: 1/2018 Document Id: 7acbac5d-d8a8-4f11-bb7b-9f28057d5212 34391-3 Set id: 4ae2bd17-292a-499a-86a7-7ab8dde7a38c Version: 1 Effective Time: 20180101 Bryant Ranch Prepack

No Title 1572456393 ⮝

Rx only

No Title 1572457776 ⮝

Rx only

Repackaging Information ⮝

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	10 mg
90	67544-671-60
180	67544-671-80
270	67544-671-92

Store between 20 -25 C (68 -77 F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20171207DKJ

Principal Display Panel - 10mg ⮝

NDC 67544-671 Baclofen 10mg - Rx Only

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-671(NDC:0603-2406) Route of Administration ORAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics Color WHITE (off-white) Score 2 pieces Shape OVAL Size 11mm Flavor Imprint Code 2265;V Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67544-671-60 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/14/2006 2 NDC:67544-671-80 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2008 3 NDC:67544-671-92 270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2008

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077156 08/30/2005

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(67544-671)

Revised: 12/2017 Document Id: ba0a7c8f-e018-4e0b-97df-8e5752eb03ad 34391-3 Set id: dd4b9972-0295-4555-a90b-bb087170cfbb Version: 1 Effective Time: 20171207 Aphena Pharma Solutions - Tennessee, LLC

Principal Display Panel ⮝

Baclofen Tablets, USP 10mg
90 Tablets
NDC 10544-172-90