URSODIOL

Product NDC

0115-1525

11-digit product format

001151525

Labeler code

0115

Product ID

0115-1525_7e106125-3176-4755-b2d0-ce17763c7ee5

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

2019-07-31

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