"0591-2368-01" National Drug Code (NDC)

Ursodiol 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-2368-01)
(Actavis Pharma, Inc.)

NDC Code0591-2368-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-2368-01)
Product NDC0591-2368
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameUrsodiol
Non-Proprietary NameUrsodiol
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20111223
Marketing Category NameANDA
Application NumberANDA200826
ManufacturerActavis Pharma, Inc.
Substance NameURSODIOL
Strength250
Strength Unitmg/1
Pharmacy ClassesBile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]

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