Rinvoq
These highlights do not include all the information needed to use RINVOQ safely and effectively. See full prescribing information for RINVOQ. RINVOQ (upadacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2019
Approved
Approval ID
2966aec7-2ef0-923c-d8ff-fe1a957bf095
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2023
Manufacturers
FDA
AbbVie Inc.
DUNS: 078458370
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Upadacitinib
PRODUCT DETAILS
NDC Product Code0074-2310
Application NumberNDA211675
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 17, 2023
Generic NameUpadacitinib
INGREDIENTS (12)
upadacitinibActive
Quantity: 30 mg in 1 1
Code: 4RA0KN46E0
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
Upadacitinib
PRODUCT DETAILS
NDC Product Code0074-1043
Application NumberNDA211675
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 17, 2023
Generic NameUpadacitinib
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
upadacitinibActive
Quantity: 45 mg in 1 1
Code: 4RA0KN46E0
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Upadacitinib
PRODUCT DETAILS
NDC Product Code0074-2306
Application NumberNDA211675
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 17, 2023
Generic NameUpadacitinib
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
upadacitinibActive
Quantity: 15 mg in 1 1
Code: 4RA0KN46E0
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT