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 Initial U.S. Approval: 1998
Approved
Approval ID
108e4cb1-6e43-44fd-b228-cd23203fccda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2015
Manufacturers
FDA
Banner Life Sciences LLC.
DUNS: 079579273
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 Code69387-103
Application NumberANDA202539
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2015
FDA Product Classification
INGREDIENTS (11)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PARICALCITOLActive
Quantity: 1 mg in 1 1
Code: 6702D36OG5
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PARICALCITOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69387-104
Application NumberANDA202539
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2015
FDA Product Classification
INGREDIENTS (12)
PARICALCITOLActive
Quantity: 2 mg in 1 1
Code: 6702D36OG5
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PARICALCITOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69387-105
Application NumberANDA202539
Product Classification
M
Marketing Category
C73584
G
Generic Name
PARICALCITOL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2015
FDA Product Classification
INGREDIENTS (12)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PARICALCITOLActive
Quantity: 4 mg in 1 1
Code: 6702D36OG5
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT