Darifenacin Hydrobromide

Product NDC

42291-207

11-digit product format

422910207

Labeler code

42291

Product ID

42291-207_9c5c3dc2-4906-7e0b-e053-2995a90a5711

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Darifenacin Hydrobromide

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA091190

Marketing category

ANDA

Marketing start

2017-01-09

Marketing end

0000-00-00

Substance

DARIFENACIN HYDROBROMIDE

Active strength

15 mg/1

Pharmacologic classes

Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record