Labetalol Hydrochloride

Product NDC

14803-502

11-digit product format

148030502

Labeler code

14803

Product ID

14803-502_86c041ec-0940-2e5b-e053-2a91aa0a2b4c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Labetalol Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

ELYSIUM PHARMACEUTICALS LIMITED

Application

ANDA207863

Marketing category

ANDA

Marketing start

2017-04-27

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record