Labetalol HCl

Product NDC

51079-928

11-digit product format

510790928

Labeler code

51079

Product ID

51079-928_7c61eb26-c81b-dad1-e053-2a91aa0a5803

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Labetalol HCl

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA075113

Marketing category

ANDA

Marketing start

2000-01-15

Marketing end

2019-11-30

Substance

LABETALOL HYDROCHLORIDE

Active strength

100 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