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

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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

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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.

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