Ursodiol

Product NDC

0904-6483

11-digit product format

009046483

Labeler code

0904

Product ID

0904-6483_6eee1538-b5f2-4d2d-b6b9-dc46c3437563

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

CAPSULE

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA079082

Marketing category

ANDA

Marketing start

2009-01-01

Marketing end

2019-07-10

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