Alendronate Sodium
These highlights do not include all the information needed to use Alendronate Sodium Tablets USP safely and effectively. See full prescribing information for Alendronate Sodium Tablets USP. ALENDRONATE Sodium Tablets USP for oral useInitial U.S. Approval: 1995
Approved
Approval ID
a9942f9c-5929-4b9b-aa27-64f7f9b164e3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2013
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-428
Application NumberANDA075710
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2013
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT