Hectorol
These highlights do not include all the information needed to use HECTOROL safely and effectively. See full prescribing information for HECTOROL. HECTOROL (doxercalciferol) capsules, for oral useHECTOROL (doxercalciferol) injection, for intravenous useInitial U.S. Approval: 1999
Approved
Approval ID
7efc3d9c-12f5-43f6-9a22-88d66cbe6f62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2023
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 3
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 Code58468-0126
Application NumberNDA021027
Product Classification
M
Marketing Category
C73594
G
Generic Name
DOXERCALCIFEROL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (8)
DOXERCALCIFEROLActive
Quantity: 2 ug in 1 mL
Code: 3DIZ9LF5Y9
Classification: ACTIB
POLYSORBATE 20Inactive
Quantity: 10 mg in 1 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 1.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Quantity: 0.02 mg in 1 mL
Code: 1P9D0Z171K
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 14.4 mg in 1 mL
Code: 70WT22SF4B
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 1.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.8 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
ALCOHOLInactive
Quantity: 0.05 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
DOXERCALCIFEROL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0123
Application NumberNDA021027
Product Classification
M
Marketing Category
C73594
G
Generic Name
DOXERCALCIFEROL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 3.6 mg in 2 mL
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 2.2 mg in 2 mL
Code: 7FLD91C86K
Classification: IACT
ALCOHOLInactive
Quantity: 0.1 mL in 2 mL
Code: 3K9958V90M
Classification: IACT
DOXERCALCIFEROLActive
Quantity: 4 ug in 2 mL
Code: 3DIZ9LF5Y9
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 3 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 28.8 mg in 2 mL
Code: 70WT22SF4B
Classification: IACT
POLYSORBATE 20Inactive
Quantity: 20 mg in 2 mL
Code: 7T1F30V5YH
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Quantity: 0.04 mg in 2 mL
Code: 1P9D0Z171K
Classification: IACT
DOXERCALCIFEROL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0127
Application NumberNDA021027
Product Classification
M
Marketing Category
C73594
G
Generic Name
DOXERCALCIFEROL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (8)
DOXERCALCIFEROLActive
Quantity: 4 ug in 2 mL
Code: 3DIZ9LF5Y9
Classification: ACTIB
POLYSORBATE 20Inactive
Quantity: 20 mg in 2 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 3 mg in 2 mL
Code: 451W47IQ8X
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Quantity: 0.04 mg in 2 mL
Code: 1P9D0Z171K
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 28.8 mg in 2 mL
Code: 70WT22SF4B
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 3.6 mg in 2 mL
Code: 593YOG76RN
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 2.2 mg in 2 mL
Code: 7FLD91C86K
Classification: IACT
ALCOHOLInactive
Quantity: 0.15 mL in 2 mL
Code: 3K9958V90M
Classification: IACT