Ursodiol

Product NDC

0615-1374

11-digit product format

006151374

Labeler code

0615

Product ID

0615-1374_d56397c5-a066-4e2d-bc5a-11b61057db4c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

CAPSULE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

NDA019594

Marketing category

NDA

Marketing start

1987-12-31

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

2017-12-31

Current FDA listing

Historical FDA.report record