Labetalol Hydrochloride

Product NDC

43199-039

11-digit product format

431990039

Labeler code

43199

Product ID

43199-039_68106801-f71a-40be-4845-45bcfa618de6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

labetalol hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

County Line Pharmaceuticals LLC

Application

NDA018716

Marketing category

NDA

Marketing start

2014-12-01

Marketing end

2020-11-01

Substance

LABETALOL HYDROCHLORIDE

Active strength

300 mg/1

Pharmacologic classes

Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record