"42385-946-01" National Drug Code (NDC)

Ursodiol 100 CAPSULE in 1 BOTTLE (42385-946-01)
(Laurus Labs Limited)

NDC Code42385-946-01
Package Description100 CAPSULE in 1 BOTTLE (42385-946-01)
Product NDC42385-946
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameUrsodiol
Non-Proprietary NameUrsodiol
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20210417
Marketing Category NameANDA
Application NumberANDA213200
ManufacturerLaurus Labs Limited
Substance NameURSODIOL
Strength300
Strength Unitmg/1
Pharmacy ClassesBile Acid [EPC], Bile Acids and Salts [CS]

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