Ursodiol

Product NDC

60687-378

11-digit product format

606870378

Labeler code

60687

Product ID

60687-378_9972f987-4010-dc67-e053-2a95a90ab7a4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

American Health Packaging

Application

ANDA200826

Marketing category

ANDA

Marketing start

2018-08-07

Marketing end

2020-12-31

Substance

URSODIOL

Active strength

250 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