NDC 69097-988

Pirfenidone

Pirfenidone

Pirfenidone is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Pirfenidone.

Product ID69097-988_161269f6-17d9-4327-bd01-b4465a784480
NDC69097-988
Product TypeHuman Prescription Drug
Proprietary NamePirfenidone
Generic NamePirfenidone
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2022-08-02
Marketing CategoryANDA /
Application NumberANDA212708
Labeler NameCipla USA Inc.
Substance NamePIRFENIDONE
Active Ingredient Strength801 mg/1
Pharm ClassesPyridone [EPC], Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69097-988-05

90 TABLET, COATED in 1 BOTTLE (69097-988-05)
Marketing Start Date2022-08-02
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
0781-8085PirfenidonePirfenidone
0781-8086PirfenidonePirfenidone
16729-467PIRFENIDONEPIRFENIDONE
16729-468PIRFENIDONEPIRFENIDONE
42385-923PirfenidonePirfenidone
42385-924PirfenidonePirfenidone
42385-925PirfenidonePirfenidone
42385-926PirfenidonePirfenidone
50228-441PIRFENIDONEPIRFENIDONE
50228-442PIRFENIDONEPIRFENIDONE
50228-443PIRFENIDONEPIRFENIDONE
60219-1640PirfenidonePirfenidone
60219-1641PirfenidonePirfenidone
60219-1642PirfenidonePirfenidone
62332-479PirfenidonePirfenidone
62332-480PirfenidonePirfenidone
69097-940PIRFENIDONEPIRFENIDONE
69097-987PirfenidonePirfenidone
69097-988PirfenidonePirfenidone
69539-119PIRFENIDONEPIRFENIDONE
69539-120PIRFENIDONEPIRFENIDONE
72205-181PIRFENIDONEPIRFENIDONE
72205-182PIRFENIDONEPIRFENIDONE
76282-715PIRFENIDONEPIRFENIDONE
50242-121ESBRIETPIRFENIDONE
50242-122ESBRIETPIRFENIDONE
50242-123ESBRIETPIRFENIDONE
64116-121Esbrietpirfenidone

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