NDC 0722-7144

Ursodiol 400 mg

Usodiol

Ursodiol 400 mg is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Nexgen Pharma, Inc. The primary component is Ursodiol.

Product ID0722-7144_4c90708e-d895-44c4-8ba2-88478fe2e01b
NDC0722-7144
Product TypeHuman Prescription Drug
Proprietary NameUrsodiol 400 mg
Generic NameUsodiol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA205789
Labeler NameNexgen Pharma, Inc
Substance NameURSODIOL
Active Ingredient Strength400 mg/1
Pharm ClassesBile Acid [EPC],Bile Acids and Salts [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0722-7144-01

100 CAPSULE in 1 BOTTLE (0722-7144-01)
Marketing Start Date2020-07-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Ursodiol 400 mg" or generic name "Usodiol"

NDCBrand NameGeneric Name
0722-7144Ursodiol 400 mgUsodiol
72887-144Ursodiol 400 mgUrsodiol
79739-7144Ursodiol 400 mgUsodiol
0722-7143Ursodiol 200 mgUsodiol
79739-7143Ursodiol 200 mgUsodiol

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