Paricalcitol
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . PARICALCITOL INJECTION, for intravenous use Initial U.S. Approval: 1998
Approved
Approval ID
4db985c4-3ba2-4967-898b-35af77f150de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paricalcitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9624
Application NumberNDA205917
Product Classification
M
Marketing Category
C73594
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PARICALCITOLActive
Quantity: 5 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
Paricalcitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9625
Application NumberNDA205917
Product Classification
M
Marketing Category
C73594
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PARICALCITOLActive
Quantity: 2 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Paricalcitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9596
Application NumberNDA205917
Product Classification
M
Marketing Category
C73594
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
PARICALCITOLActive
Quantity: 5 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT