Doxercalciferol
These highlights do not include all the information needed to use DOXERCALCIFEROL INJECTION safely and effectively. See full prescribing information for DOXERCALCIFEROL INJECTION. DOXERCALCIFEROL injection, for intravenous use Initial U.S. Approval: 1999
Approved
Approval ID
253367e2-ae31-4196-9571-71f560283cf3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 2019
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxercalciferol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1393
Application NumberANDA208974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (8)
DOXERCALCIFEROLActive
Quantity: 2 ug in 1 mL
Code: 3DIZ9LF5Y9
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
Doxercalciferol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1392
Application NumberANDA208974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
DOXERCALCIFEROLActive
Quantity: 4 ug in 2 mL
Code: 3DIZ9LF5Y9
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT