Alendronate Sodium: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container label
Alendronate Sodium Oral Solution, 70 mg/75 mL

container
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Carton labelAlendronate Sodium Oral Solution, 70 mg/75 mL

carton
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ALENDRONATE SODIUM alendronate sodium solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-264
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
WATER
SACCHARIN SODIUM MONOHYDRATE
SODIUM CITRATE
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:70954-264-10 4 BOTTLE in 1 CARTON contains a BOTTLE
1 75 mL in 1 BOTTLE This package is contained within the CARTON (70954-264-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214512 05/24/2023
Labeler — ANI Pharmaceuticals, Inc. (145588013)
Establishment
Name Address ID/FEI Operations
Novitium Pharma LLC 080301870 ANALYSIS (70954-264), LABEL (70954-264), MANUFACTURE (70954-264), PACK (70954-264)

Revised: 05/2023 ANI Pharmaceuticals, Inc.

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