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
4adfa72a-abef-34db-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 11, 2021
Manufacturers
FDA
NuCare Pharmaceuticals, Inc.
DUNS: 010632300
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 Code68071-3171
Application NumberANDA076768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alendronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 35 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT