MedPath

Hydralazine

Generic Name
Hydralazine
Brand Names
Apresoline, Bidil
Drug Type
Small Molecule
Chemical Formula
C8H8N4
CAS Number
86-54-4
Unique Ingredient Identifier
26NAK24LS8

Overview

Originally developed in the 1950s as a malaria treatment, hydralazine showed antihypertensive ability and was soon repurposed. Hydralazine is a hydrazine derivative vasodilator used alone or as adjunct therapy in the treatment of hypertension and only as adjunct therapy in the treatment of heart failure. Hydralazine is no longer a first line therapy for these indications since the development of newer antihypertensive medications. Hydralazine hydrochloride was FDA approved on 15 January 1953.

Background

Originally developed in the 1950s as a malaria treatment, hydralazine showed antihypertensive ability and was soon repurposed. Hydralazine is a hydrazine derivative vasodilator used alone or as adjunct therapy in the treatment of hypertension and only as adjunct therapy in the treatment of heart failure. Hydralazine is no longer a first line therapy for these indications since the development of newer antihypertensive medications. Hydralazine hydrochloride was FDA approved on 15 January 1953.

Indication

Hydralazine is indicated alone or adjunct to standard therapy to treat essential hypertension. A combination product with isosorbide dinitrate is indicated as an adjunct therapy in the treatment of heart failure.

Associated Conditions

  • Heart Failure
  • Hypertension, Essential Hypertension
  • Hypertensive crisis
  • Severe Hypertension

FDA Approved Products

HYDRALAZINE HYDROCHLORIDE
Manufacturer:Rebel Distributors Corp
Route:ORAL
Strength:25 mg in 1 1
Approved: 2008/09/19
NDC:21695-680
HYDRALAZINE HYDROCHLORIDE
Manufacturer:Rebel Distributors Corp
Route:ORAL
Strength:100 mg in 1 1
Approved: 2008/09/19
NDC:21695-695
Hydralazine Hydrochloride
Manufacturer:Mylan Institutional Inc.
Route:ORAL
Strength:50 mg in 1 1
Approved: 2023/03/31
NDC:51079-076
HYDRALAZINE HYDROCHLORIDE
Manufacturer:Rebel Distributors Corp
Route:ORAL
Strength:50 mg in 1 1
Approved: 2008/09/19
NDC:21695-694
Hydralazine Hydrochloride
Manufacturer:Mylan Institutional Inc.
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/03/31
NDC:51079-075

Singapore Approved Products

HYDRALAZINE TABLET 50 mg
Manufacturer:BEACONS PHARMACEUTICALS PTE. LTD.
Form:TABLET, FILM COATED
Strength:50 mg
Online:Yes
Approved: 1988/05/12
Approval:SIN01089P
APO-HYDRALAZINE TABLET 50 mg
Manufacturer:APOTEX INC
Form:TABLET, FILM COATED
Strength:50 mg
Online:Yes
Approved: 1988/05/13
Approval:SIN01148P
APO-HYDRALAZINE TABLET 10 mg
Manufacturer:APOTEX INC
Form:TABLET
Strength:10 mg
Online:Yes
Approved: 1988/04/05
Approval:SIN00211P
HYDRALAZINE TABLETS 10 mg
Manufacturer:BEACONS PHARMACEUTICALS PTE. LTD.
Form:TABLET, FILM COATED
Strength:10 mg
Online:Yes
Approved: 1988/05/13
Approval:SIN01086P
APO-HYDRALAZINE TABLET 25 mg
Manufacturer:APOTEX INC
Form:TABLET, FILM COATED
Strength:25 mg
Online:Yes
Approved: 1988/04/05
Approval:SIN00210P

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