NDC Code(s) : 70954-264-10
Packager : ANI Pharmaceuticals, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alendronate Sodium Alendronate Sodium SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:70954-264
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID70 mg in 75 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM MONOHYDRATE(UNII: A9CO00M9HV)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
Product Characteristics
Color PINK (Colorless to pale pink) Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70954-264-104 in 1 CARTON 24/05/2023
175 mL in 1 BOTTLE Type 0: Not a Combination Product
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 Business Operations
Novitium Pharma LLC 080301870 ANALYSIS(70954-264), LABEL(70954-264), MANUFACTURE(70954-264), PACK(70954-264)

PRINCIPAL DISPLAY PANEL

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

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