PIRFENIDONE
These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively.See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE film-coated tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
fab59395-1c5d-4c64-ba47-34d75736e983
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PIRFENIDONE
PRODUCT DETAILS
NDC Product Code16729-468
Application NumberANDA212730
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 6, 2023
Generic NamePIRFENIDONE
INGREDIENTS (11)
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PIRFENIDONEActive
Quantity: 801 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
PIRFENIDONE
PRODUCT DETAILS
NDC Product Code16729-467
Application NumberANDA212730
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 6, 2023
Generic NamePIRFENIDONE
INGREDIENTS (10)
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB