Actigall

Product NDC

52544-930

11-digit product format

525440930

Labeler code

52544

Product ID

52544-930_f8d576c5-4143-4fa4-84b7-a0559315a8b7

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

CAPSULE

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

NDA019594

Marketing category

NDA

Marketing start

1987-12-31

Marketing end

2020-02-29

Substance

URSODIOL

Active strength

300 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