FOSAMAX PLUS D
These highlights do not include all the information needed to use FOSAMAX PLUS D safely and effectively. See full prescribing information for FOSAMAX PLUS D. FOSAMAX PLUS D(alendronate sodium/cholecalciferol) tabletsInitial U.S. Approval: 2005
Approved
Approval ID
10307e7e-9a84-4aa1-8c5c-4b209cffe4d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2023
Manufacturers
FDA
Organon LLC
DUNS: 117494753
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ALENDRONATE SODIUM and CHOLECALCIFEROL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78206-136
Application NumberNDA021762
Product Classification
M
Marketing Category
C73594
G
Generic Name
ALENDRONATE SODIUM and CHOLECALCIFEROL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (13)
CHOLECALCIFEROLActive
Quantity: 5600 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM ALUMINOSILICATEInactive
Code: 058TS43PSM
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ALENDRONATE SODIUM and CHOLECALCIFEROL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78206-137
Application NumberNDA021762
Product Classification
M
Marketing Category
C73594
G
Generic Name
ALENDRONATE SODIUM and CHOLECALCIFEROL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (13)
ALENDRONATE SODIUMActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM ALUMINOSILICATEInactive
Code: 058TS43PSM
Classification: IACT
CHOLECALCIFEROLActive
Quantity: 2800 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT