NDC 60219-1642

Pirfenidone

Pirfenidone

Pirfenidone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Pirfenidone.

Product ID60219-1642_5d423ea4-5071-42f8-86fb-669381c7657c
NDC60219-1642
Product TypeHuman Prescription Drug
Proprietary NamePirfenidone
Generic NamePirfenidone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-01-07
Marketing CategoryANDA /
Application NumberANDA212569
Labeler NameAmneal Pharmaceuticals NY LLC
Substance NamePIRFENIDONE
Active Ingredient Strength267 mg/1
Pharm ClassesPyridone [EPC],Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 60219-1642-7

1 BOTTLE in 1 CARTON (60219-1642-7) > 270 CAPSULE in 1 BOTTLE
Marketing Start Date2022-01-07
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
60219-1642PirfenidonePirfenidone
50242-121ESBRIETPIRFENIDONE
50242-122ESBRIETPIRFENIDONE
50242-123ESBRIETPIRFENIDONE
64116-121Esbrietpirfenidone

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