NDC 42571-336

Pirfenidone

Pirfenidone

Pirfenidone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Pirfenidone.

Product ID42571-336_dfe86a9c-aadf-4b6c-e053-2995a90a23c8
NDC42571-336
Product TypeHuman Prescription Drug
Proprietary NamePirfenidone
Generic NamePirfenidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-12-01
Marketing CategoryANDA /
Application NumberANDA212680
Labeler NameMicro Labs Limited
Substance NamePIRFENIDONE
Active Ingredient Strength801 mg/1
Pharm ClassesPyridone [EPC], Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42571-336-90

90 BOTTLE in 1 CARTON (42571-336-90) > 90 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2022-12-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Pirfenidone" or generic name "Pirfenidone"

NDCBrand NameGeneric Name
0480-3610PirfenidonePirfenidone
0480-3611PirfenidonePirfenidone
0781-2158PirfenidonePirfenidone
0781-8085PirfenidonePirfenidone
0781-8086PirfenidonePirfenidone
16729-467PIRFENIDONEPIRFENIDONE
16729-468PIRFENIDONEPIRFENIDONE
31722-872PirfenidonePirfenidone
31722-873PirfenidonePirfenidone
42385-923PirfenidonePirfenidone
42385-924PirfenidonePirfenidone
42385-925PirfenidonePirfenidone
42385-926PirfenidonePirfenidone
42571-335PirfenidonePirfenidone
42571-336PirfenidonePirfenidone
50228-441PIRFENIDONEPIRFENIDONE
50228-442PIRFENIDONEPIRFENIDONE
50228-443PIRFENIDONEPIRFENIDONE
60219-1640PirfenidonePirfenidone
60219-1641PirfenidonePirfenidone
60219-1642PirfenidonePirfenidone
62332-479PirfenidonePirfenidone
50242-121ESBRIETPIRFENIDONE
50242-122ESBRIETPIRFENIDONE
50242-123ESBRIETPIRFENIDONE

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