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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-468
Application NumberANDA212730
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIRFENIDONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-467
Application NumberANDA212730
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIRFENIDONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification
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