MedPath
FDA Product

PIRFENIDONE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

PIRFENIDONE

0904-7397

Regulatory Information

0904-7397

ANDA212772

C73584

October 31, 2023

USA

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

Human Prescription Drug Label

1

Company Information

191427277

Active Ingredients

PIRFENIDONE

Quantity: 267 mg in 1 1

Code: D7NLD2JX7U

Class Code: ACTIB

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POLYVINYL ALCOHOL

Code: 532B59J990

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

PIRFENIDONE

Code: D7NLD2JX7U

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