Labetalol Hydrochloride

Product NDC

51991-935

11-digit product format

519910935

Labeler code

51991

Product ID

51991-935_9ad7c547-abaa-46af-a0f0-2b0c78440ad9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Labetalol Hydrochloride

Dosage form

INJECTION, SOLUTION

Route

INTRAVENOUS

Labeler

Breckenridge Pharmaceutical, Inc.

Application

ANDA090699

Marketing category

ANDA

Marketing start

2017-03-15

Marketing end

2021-01-31

Substance

LABETALOL HYDROCHLORIDE

Active strength

5 mg/mL

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