Alendronate Sodium
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. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
873442b0-1932-4fa6-ba25-b4d3505f4128
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5474
Application NumberANDA090124
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 29, 2022
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 35 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT