PIRFENIDONE
These highlights do not include all the information needed to use PIRFENIDONE CAPSULES, safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
1709582c-9975-4dc1-8181-2501ee670eef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2023
Manufacturers
FDA
EXELAN PHARMACEUTICALS INC.
DUNS: 967795266
Products 1
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 Code76282-715
Application NumberANDA212077
Product Classification
M
Marketing Category
C73584
G
Generic Name
PIRFENIDONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT