Alendronate Sodium
ALENDRONATE SODIUM TABLETS, USP
Approved
Approval ID
62af73fb-c9b7-4034-9794-dbb50420e62b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2010
Manufacturers
FDA
Dispensing Solutions Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alendronate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68258-3014
Application NumberANDA076984
Product Classification
M
Marketing Category
C73584
G
Generic Name
alendronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2010
FDA Product Classification
INGREDIENTS (5)
ALENDRONATE SODIUMActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT