NDC 76282-715

PIRFENIDONE

Pirfenidone

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

Product ID76282-715_17000a04-f649-4924-b543-efa85178d60d
NDC76282-715
Product TypeHuman Prescription Drug
Proprietary NamePIRFENIDONE
Generic NamePirfenidone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-08-02
Marketing CategoryANDA /
Application NumberANDA212077
Labeler NameEXELAN PHARMACEUTICALS INC.
Substance NamePIRFENIDONE
Active Ingredient Strength267 mg/1
Pharm ClassesPyridone [EPC], Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 76282-715-27

270 CAPSULE in 1 BOTTLE (76282-715-27)
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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