Labetalol Hydrochloride

Product NDC

69292-503

11-digit product format

692920503

Labeler code

69292

Product ID

69292-503_7a6f28ce-1e7c-4a61-9fbc-ae4d45b54c1d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Labetalol Hydrochloride

Dosage form

TABLET, COATED

Route

ORAL

Labeler

AMICI PHARMACEUTICALS LLC

Application

ANDA075215

Marketing category

ANDA

Marketing start

2018-05-01

Marketing end

0000-00-00

Substance

LABETALOL

Active strength

300 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record