NDC 42385-925

Pirfenidone

Pirfenidone

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

Product ID42385-925_29b0fd0e-5a2b-4da7-8524-177dc28bf55e
NDC42385-925
Product TypeHuman Prescription Drug
Proprietary NamePirfenidone
Generic NamePirfenidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-07-19
Marketing CategoryANDA /
Application NumberANDA212722
Labeler NameLaurus Labs Limited
Substance NamePIRFENIDONE
Active Ingredient Strength534 mg/1
Pharm ClassesPyridone [EPC], Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42385-925-90

90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90)
Marketing Start Date2022-07-19
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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