NDC 69097-940

PIRFENIDONE

Pirfenidone

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

Product ID69097-940_160109da-da53-45a8-840a-e41384710033
NDC69097-940
Product TypeHuman Prescription Drug
Proprietary NamePIRFENIDONE
Generic NamePirfenidone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-08-02
Marketing CategoryANDA /
Application NumberANDA212077
Labeler NameCipla USA Inc.
Substance NamePIRFENIDONE
Active Ingredient Strength267 mg/1
Pharm ClassesPyridone [EPC], Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 69097-940-04

90 CAPSULE in 1 BOTTLE (69097-940-04)
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
0781-2158PirfenidonePirfenidone
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.