Pirfenidone
These highlights do not include all the information needed to use PIRFENIDONE CAPSULES and TABLETS safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES and TABLETS. PIRFENIDONE capsules and film-coated tablets, for oral use Initial U.S. Approval: 2014
Approved
Approval ID
29b0fd0e-5a2b-4da7-8524-177dc28bf55e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2023
Manufacturers
FDA
Laurus Labs Limited
DUNS: 915075687
Products 4
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 Code42385-925
Application NumberANDA212722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (12)
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PIRFENIDONEActive
Quantity: 534 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Pirfenidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-926
Application NumberANDA212722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (13)
PIRFENIDONEActive
Quantity: 801 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Pirfenidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-924
Application NumberANDA212722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (12)
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Pirfenidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-923
Application NumberANDA212724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pirfenidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2023
FDA Product Classification
INGREDIENTS (10)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
PIRFENIDONEActive
Quantity: 267 mg in 1 1
Code: D7NLD2JX7U
Classification: ACTIB
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT