Alendronate Sodium
ALENDRONATE SODIUM TABLETS, USP
Approved
Approval ID
eb668bf3-aab0-4529-bf8f-e740a5d5f3b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-902
Application NumberANDA076768
Product Classification
M
Marketing Category
C73584
G
Generic Name
alendronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 10, 2009
FDA Product Classification
INGREDIENTS (6)
alendronate sodiumActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
alendronate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-901
Application NumberANDA076768
Product Classification
M
Marketing Category
C73584
G
Generic Name
alendronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
alendronate sodiumActive
Quantity: 35 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT