Labetalol Hydrochloride

Product NDC

0615-4539

11-digit product format

006154539

Labeler code

0615

Product ID

0615-4539_923bfb04-e1ec-4651-8d15-a7f93a8e8b1c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Labetalol Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA074787

Marketing category

ANDA

Marketing start

2010-01-14

Marketing end

0000-00-00

Substance

LABETALOL HYDROCHLORIDE

Active strength

200 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record