Ursodiol

Product NDC

68788-6807

11-digit product format

687886807

Labeler code

68788

Product ID

68788-6807_0956de91-d1b6-4e41-947c-5de1bad31d85

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

CAPSULE

Route

ORAL

Labeler

Preferred Pharmaceuticals Inc.

Application

NDA019594

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2016-11-07

Marketing end

0000-00-00

Substance

URSODIOL

Active strength

300 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record