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Labetalol

Generic Name
Labetalol
Brand Names
Trandate
Drug Type
Small Molecule
Chemical Formula
C19H24N2O3
CAS Number
36894-69-6
Unique Ingredient Identifier
R5H8897N95

Overview

Labetalol is a racemic mixture of 2 diastereoisomers where dilevalol, the R,R' stereoisomer, makes up 25% of the mixture. Labetalol is formulated as an injection or tablets to treat hypertension. Labetalol was granted FDA approval on 1 August 1984.

Background

Labetalol is a racemic mixture of 2 diastereoisomers where dilevalol, the R,R' stereoisomer, makes up 25% of the mixture. Labetalol is formulated as an injection or tablets to treat hypertension. Labetalol was granted FDA approval on 1 August 1984.

Indication

Labetalol injections are indicated to control blood pressure in severe hypertension. Labetalol tablets are indicated alone or in combination with antihypertensives like thiazides and loop diuretics to manage hypertension.

Associated Conditions

  • Chronic Stable Angina Pectoris
  • Hypertension
  • Hypertensive Emergency
  • Hypertensive crisis
  • Pheochromocytoma
  • Subarachnoid Hemorrhage

FDA Approved Products

Labetalol HCL
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:300 mg in 1 1
Approved: 2019/11/14
NDC:63629-9185
Labetalol Hydrochloride
Manufacturer:BluePoint Laboratories Inc.
Route:ORAL
Strength:300 mg in 1 1
Approved: 2023/07/04
NDC:68001-383
Labetalol Hydrochloride
Manufacturer:Fosun Pharma USA Inc.
Route:INTRAVENOUS
Strength:5 mg in 1 mL
Approved: 2020/07/09
NDC:72266-103
Labetalol HCL
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/08/11
NDC:63629-2214
Labetalol Hydrochloride
Manufacturer:Fosun Pharma USA Inc.
Route:INTRAVENOUS
Strength:5 mg in 1 mL
Approved: 2021/03/28
NDC:72266-103

Singapore Approved Products

TRANDATE INJECTION 100 mg/20 ml
Manufacturer:UBI Pharma Inc
Form:INJECTION
Strength:100 mg/20 ml
Online:Yes
Approved: 1988/07/14
Approval:SIN02281P
TRANTALOL TABLET 100 mg
Manufacturer:DUOPHARMA (M) SDN BHD
Form:TABLET
Strength:100 mg
Online:Yes
Approved: 1990/10/24
Approval:SIN05162P

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