"76282-716-27" National Drug Code (NDC)

Pirfenidone 270 TABLET, COATED in 1 BOTTLE (76282-716-27)
(EXELAN PHARMACEUTICALS INC.)

NDC Code76282-716-27
Package Description270 TABLET, COATED in 1 BOTTLE (76282-716-27)
Product NDC76282-716
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePirfenidone
Non-Proprietary NamePirfenidone
Dosage FormTABLET, COATED
UsageORAL
Start Marketing Date20220802
Marketing Category NameANDA
Application NumberANDA212078
ManufacturerEXELAN PHARMACEUTICALS INC.
Substance NamePIRFENIDONE
Strength801
Strength Unitmg/1
Pharmacy ClassesPyridone [EPC], Pyridones [CS]

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