Paricalcitol
These highlights do not include all the information needed to use PARICALCITOL CAPSULES safely and effectively. See Full Prescribing Information for PARICALCITOL CAPSULES. PARICALCITOL capsules, for oral use Initial U.S. Approval:1998
Approved
Approval ID
0fbaff52-f08f-42b7-8e46-c7214112901a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2017
Manufacturers
FDA
MARKSANS PHARMA LIMITED
DUNS: 925822975
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 Code25000-014
Application NumberANDA204948
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2017
FDA Product Classification
INGREDIENTS (15)
PARICALCITOLActive
Quantity: 2 ug in 1 1
Code: 6702D36OG5
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Paricalcitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-017
Application NumberANDA204948
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2017
FDA Product Classification
INGREDIENTS (14)
PARICALCITOLActive
Quantity: 4 ug in 1 1
Code: 6702D36OG5
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Paricalcitol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25000-012
Application NumberANDA204948
Product Classification
M
Marketing Category
C73584
G
Generic Name
Paricalcitol
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2017
FDA Product Classification
INGREDIENTS (14)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PARICALCITOLActive
Quantity: 1 ug in 1 1
Code: 6702D36OG5
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT