URSODIOL

Product NDC

0115-9934

11-digit product format

001159934

Labeler code

0115

Product ID

0115-9934_b8814af2-d7df-44b0-b22e-a63dcd0768b9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

URSODIOL

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Impax Generics

Application

ANDA200826

Marketing category

ANDA

Marketing start

2011-12-23

Marketing end

2020-08-31

Substance

URSODIOL

Active strength

500 mg/1

Pharmacologic classes

Bile Acid [EPC],Bile Acids and Salts [CS]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record