PONVORY
These highlights do not include all the information needed to use PONVORY safely and effectively. See full prescribing information for PONVORY. PONVORY (ponesimod) tablets, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
5be69660-738c-4db7-b0d4-517aa873dc41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Janssen Pharmaceuticals, Inc
DUNS: 063137772
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ponesimod
PRODUCT DETAILS
NDC Product Code50458-707
Application NumberNDA213498
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateAugust 16, 2023
Generic NamePonesimod
Ponesimod
PRODUCT DETAILS
NDC Product Code50458-720
Application NumberNDA213498
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 16, 2023
Generic NamePonesimod
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PONESIMODActive
Quantity: 20 mg in 1 1
Code: 5G7AKV2MKP
Classification: ACTIB