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
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