Alendronate Sodium (Page 8 of 8)

Hikma Pharmaceuticals USA Inc. 1 September 2020

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Alendronate Sodium Oral Solution, 70mg/75ml

: 0054-0282 -59

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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Alendronate Sodium (Page 8 of 8)

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