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
f0d79a1b-c7fb-4521-941a-5d6c2fd50170
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2019
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-359
Application NumberANDA210452
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2019
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
BUTYLATED HYDROXYTOLUENEInactive
Quantity: 0.04 mg in 2 mL
Code: 1P9D0Z171K
Classification: IACT
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
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 3.6 mg in 2 mL
Code: 593YOG76RN
Classification: IACT
ALCOHOLInactive
Quantity: 0.15 mL in 2 mL
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 2.2 mg in 2 mL
Code: 7FLD91C86K
Classification: IACT
Doxercalciferol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68083-300
Application NumberANDA210452
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2019
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
BUTYLATED HYDROXYTOLUENEInactive
Quantity: 0.04 mg in 2 mL
Code: 1P9D0Z171K
Classification: IACT
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
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