Ursodiol

Product NDC

42291-850

11-digit product format

422910850

Labeler code

42291

Product ID

42291-850_641a64da-2793-298a-e053-2991aa0ae8ed

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ursodiol

Dosage form

CAPSULE

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA075517

Marketing category

ANDA

Marketing start

2010-07-16

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record