Alendronate Sodium (Page 9 of 9)

Package/Label Display Panel-35mg 12 (3 x 4) Unit-Dose Tablets

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

GSMS, Inc. NDC 60429-055-72

Alendronate Sodium Tablets, USP 35 mg

Rx

12 (3 x 4) Unit-Dose Tablets

Once Weekly

Alendronate Sodium Tablets, USP 35 mg*

* EACH TABLET CONTAINS 45.69 mg alendronate sodium (35 mg free acid equivalent).
USUAL ADULT DOSAGE: One 35 mg tablet once weekly. See accompanying package insert for complete dosage information.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

This package not intended for household use. For institutional use only. Package not child resistant

Package/Label Display Panel-70mg 12 (3 x 4) Unit-Dose Tablets

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

GSMS, Inc. NDC 60429-056-72

Alendronate Sodium Tablets, USP

70 mg

Rx

12 (3 x 4) Unit-Dose Tablets

* EACH TABLET CONTAINS 91.37 mg alendronate sodium (70 mg free acid equivalent).
USUAL ADULT DOSAGE: One 70 mg tablet once weekly. See accompanying package insert for complete dosage information.

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

This package not intended for household use. For institutional use only. Package not child resistant

ALENDRONATE SODIUM alendronate sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-055 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 35 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE

Product Characteristics Color white (off-white) Score no score Shape OVAL (modified, debossed) Size 10mm Flavor Imprint Code AP207 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60429-055-74 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60429-055-74) 2 NDC:60429-055-72 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60429-055-72)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090258 04/03/2014

ALENDRONATE SODIUM alendronate sodium tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-056 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 70 mg

Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE

Product Characteristics Color white (off-white) Score no score Shape OVAL (modified, debossed) Size 13mm Flavor Imprint Code AP205 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60429-056-74 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60429-056-74) 2 NDC:60429-056-72 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (60429-056-72)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090258 04/03/2014

Labeler — Golden State Medical Supply, Inc. (603184490)

Establishment
Name	Address	ID/FEI	Operations
Austarpharma, LLC		362785011	manufacture (60429-055), manufacture (60429-056)

Establishment
Name	Address	ID/FEI	Operations
Golden State Medical Supply, Inc.		603184490	repack (60429-055), repack (60429-056), relabel (60429-055), relabel (60429-056)

Revised: 01/2020 Golden State Medical Supply, Inc.