Ursodiol

Product NDC

68001-227

11-digit product format

680010227

Labeler code

68001

Product ID

68001-227_e243455a-5c04-4036-99cc-93aa9c891b6b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

BluePoint Laboratories

Application

ANDA200826

Marketing category

ANDA

Marketing start

2014-02-27

Marketing end

0000-00-00

Substance

URSODIOL

Active strength

500 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record