ALENDRONATE SODIUM- alendronate sodium tablet 
Blu Pharmaceuticals, LLC

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These highlights do not include all the information needed to use alendronate sodium tablets safely and effectively. See full prescribing information for alendronate sodium tablets USP.

Alendronate Sodium Tablets USP  for oral use
Initial U.S. Approval: 1995

16 HOW SUPPLIED

Principal display Panel

Alendronate Sodium Tablets 35 mg - 4 Count Carton

Blu Pharmaceuticals

4ct

Alendronate Sodium Tablets 70 mg - 4 Count Carton

Blu Pharmaceuticals

4 ct
ALENDRONATE SODIUM 
alendronate sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24658-162
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P) ALENDRONIC ACID35 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeOVAL (Modified Oval) Size13mm
FlavorImprint Code AP207
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24658-162-733 in 1 CARTON02/05/201303/31/2015
1NDC:24658-162-714 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09025802/05/201303/31/2015
ALENDRONATE SODIUM 
alendronate sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24658-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P) ALENDRONIC ACID70 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeOVAL (Modified Oval) Size16mm
FlavorImprint Code AP205
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24658-163-733 in 1 CARTON02/05/201303/31/2015
1NDC:24658-163-714 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09025802/05/201303/31/2015
Labeler - Blu Pharmaceuticals, LLC (784445061)

Revised: 5/2016
 
Blu Pharmaceuticals, LLC