Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Banner Pharmacaps Inc.
Banner Life Sciences LLC.
945494508
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PARICALCITOL
Product Details
NDC Product Code
69387-103Application Number
ANDA202539Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 15, 2015FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ParicalcitolActive
Code: 6702D36OG5Class: ACTIBQuantity: 1 mg in 1 1
WATERInactive
Code: 059QF0KO0RClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PARICALCITOL
Product Details
NDC Product Code
69387-104Application Number
ANDA202539Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 15, 2015ParicalcitolActive
Code: 6702D36OG5Class: ACTIBQuantity: 2 mg in 1 1
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PARICALCITOL
Product Details
NDC Product Code
69387-105Application Number
ANDA202539Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 15, 2015ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
ParicalcitolActive
Code: 6702D36OG5Class: ACTIBQuantity: 4 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT