Alendronate Sodium (Page 8 of 8)

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Alendronate Sodium Oral Solution, 70mg/75ml

0054-0282 -59
0054-0282-59
(click image for full-size original)
ALENDRONATE SODIUM alendronate sodium solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0282
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alendronate Sodium (Alendronic acid) Alendronic acid 70 mg in 75 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
methylparaben
propylparaben
saccharin sodium
SODIUM CITRATE, UNSPECIFIED FORM
Product Characteristics
Color PINK (Colorless to pale pink) Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0282-59 4 BOTTLE, UNIT-DOSE in 1 CARTON contains a BOTTLE, UNIT-DOSE
1 75 mL in 1 BOTTLE, UNIT-DOSE This package is contained within the CARTON (0054-0282-59)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090520 10/30/2020
Labeler — Hikma Pharmaceuticals USA Inc. (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-0282)

Revised: 09/2020 Hikma Pharmaceuticals USA Inc.

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