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 tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
6e4f991a-c9e3-4121-97d0-d07954f17336
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-479
Application NumberANDA212708
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (11)
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Pirfenidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-480
Application NumberANDA212708
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
PIRFENIDONEActive
Quantity: 801 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT