Alendronate Sodium (Page 8 of 8)

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Alendronate Sodium 70mg Tablets #4
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Alendronate Sodium Tablets USP 70 mg 4s Box Text

NDC 0093-5171- 44

Once Weekly
ALENDRONATE SODIUM Tablets USP
70 mg*

*Each tablet contains 91.37 mg alendronate sodium trihydrate
(70 mg free acid equivalent).

USUAL ADULT DOSAGE:
ONE 70 mg TABLET ONCE WEEKLY

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

See accompanying circular for complete dosage information.

Unit-of-Use dispense in original package.

Important information:

Please read the enclosed Medication Guide before taking Once Weekly alendronate
sodium tablets. Keep this and all drugs out of the reach of children.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Rx only

4 TABLETS

TEVA

ALENDRONATE SODIUM
alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-428(NDC:0093-5171)
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape SQUARE (pillow-shaped) Size 8mm
Flavor Imprint Code 93;5171
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-428-04 4 TABLET in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075710 02/06/2008
Labeler — MedVantx, Inc. (806427725)
Registrant — Teva Pharmaceuticals USA Inc (118234421)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 REPACK (66116-428)

Revised: 07/2013 MedVantx, Inc.

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