"0115-1525-01" National Drug Code (NDC)

Ursodiol 100 TABLET, FILM COATED in 1 BOTTLE (0115-1525-01)
(Impax Generics)

NDC Code0115-1525-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (0115-1525-01)
Product NDC0115-1525
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameUrsodiol
Non-Proprietary NameUrsodiol
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20111223
End Marketing Date20190731
Marketing Category NameANDA
Application NumberANDA200826
ManufacturerImpax Generics
Substance NameURSODIOL
Strength500
Strength Unitmg/1
Pharmacy ClassesBile Acid [EPC],Bile Acids and Salts [CS]

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