Alendronate Sodium (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 35 mg

Rx Only
Once Weekly
Alendronate
Sodium Tablets, USP
35 mg4 Tablets

Alendronate Sodium, USP tablet
(click image for full-size original)

Alendronate Sodium, USP tablet

ALENDRONATE SODIUM alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-321(NDC:16252-599)
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
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code AN35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-321-01 4 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076984 05/01/2017
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 09/2017 Aidarex Pharmaceuticals LLC

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