Paricalcitol
These highlights do not include all the information needed to use PARICALCITOL INJECTION safely and effectively. See full prescribing information for PARICALCITOL INJECTION. PARICALCITOL injection, for intravenous useInitial U.S. Approval: 1998
Approved
Approval ID
8e0b016c-4bda-487e-b525-63abfb772761
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2019
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Paricalcitol
PRODUCT DETAILS
NDC Product Code70121-1035
Application NumberANDA206699
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 25, 2019
Generic NameParicalcitol
INGREDIENTS (4)
PARICALCITOLActive
Quantity: 10 ug in 2 mL
Code: 6702D36OG5
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Paricalcitol
PRODUCT DETAILS
NDC Product Code70121-1036
Application NumberANDA206699
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 25, 2019
Generic NameParicalcitol
INGREDIENTS (4)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PARICALCITOLActive
Quantity: 10 ug in 2 mL
Code: 6702D36OG5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
Paricalcitol
PRODUCT DETAILS
NDC Product Code70121-1034
Application NumberANDA206699
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 25, 2019
Generic NameParicalcitol
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PARICALCITOLActive
Quantity: 5 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Paricalcitol
PRODUCT DETAILS
NDC Product Code70121-1033
Application NumberANDA206699
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 25, 2019
Generic NameParicalcitol
INGREDIENTS (4)
PARICALCITOLActive
Quantity: 2 ug in 1 mL
Code: 6702D36OG5
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT