Ursodiol

Product NDC

68084-892

11-digit product format

680840892

Labeler code

68084

Product ID

68084-892_7537d11c-0977-aab5-e053-2991aa0af30e

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

2015-10-01

Marketing end

2019-08-31

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