Active substance
Hydralazine
- SFDA 9
- US FDA 89
- Health Canada 14
- US price lines 4
- NHS prices 2
- WHO EML 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Aprolin | 25 mg | Tablet · Oral use | 100 Bottle | SAR 50.00 | Generic · Prescription | Saudi Amarox | Valid |
| Aprolin | 50 mg | Tablet · Oral use | 100 Container | SAR 100.00 | Generic · Prescription | Saudi Amarox | Valid |
| Aprolin | 10 mg | Tablet · Oral use | 100 Container | SAR 20.00 | Generic · Prescription | Saudi Amarox | Valid |
| Barolex | 50 mg | Tablet · Oral use | 30 Blister | SAR 30.00 | Generic · Prescription | Al-Taqaddom pharmaceutical Industries | Valid |
| Barolex | 25 mg | Tablet · Oral use | 30 Blister | SAR 15.00 | Generic · Prescription | Al-Taqaddom pharmaceutical Industries | Valid |
| Hydralazine Sciegen | 50 mg | Tablet · Oral use | 30 Bottle | SAR 30.00 | Generic · Prescription | ScieGen Pharmaceuticals, Inc | Valid |
| Hydralazine Sciegen | 25 mg | Tablet · Oral use | 30 Bottle | SAR 15.00 | Generic · Prescription | ScieGen Pharmaceuticals, Inc | Valid |
| APRESOLINE 20MG-ML INJ | 20 mg/ml | Injection · Intravenous use | 5 Ampoule | SAR 41.95 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| HYDRALAZINE HCL TAB 25MG | 25 mg | Tablet · Oral use | 100 Tablet Container | SAR 13.70 | NCE · Prescription | WYETH | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
CARDIOMYOPATHY; CONGESTIVE HEART FAILURE; PRE-ECLAMPSIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | 25MG | tablet · oral | PLIVA | Prescription | 1 May 1984 |
| HYDRALAZINE HYDROCHLORIDE | 50MG | tablet · oral | PLIVA | Prescription | 1 May 1984 |
| HYDRALAZINE HYDROCHLORIDE | 10MG | tablet · oral | PLIVA | Prescription | 18 Dec 1985 |
| HYDRALAZINE HYDROCHLORIDE | 100MG | tablet · oral | PLIVA | Prescription | 18 Dec 1985 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | AM REGENT | Prescription | 30 Jun 1997 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | FRESENIUS KABI USA | Prescription | 13 Mar 2001 |
| HYDRALAZINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 100MG | tablet · oral | HETERO LABS LTD III | Prescription | 12 Sep 2008 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | RISING | Prescription | 21 Apr 2009 |
| HYDRALAZINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 100MG | tablet · oral | GLENMARK PHARMS LTD | Prescription | 29 May 2009 |
| HYDRALAZINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 100MG | tablet · oral | HERITAGE PHARMS INC | Prescription | 26 Feb 2010 |
| HYDRALAZINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 100MG | tablet · oral | ALKEM LABS LTD | Prescription | 7 Dec 2012 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | NAVINTA LLC | Prescription | 28 Mar 2013 |
| HYDRALAZINE HYDROCHLORIDE | 25MG; 50MG; 100MG | tablet · oral | STRIDES PHARMA | Prescription | 3 May 2013 |
| HYDRALAZINE HYDROCHLORIDE | 25MG; 50MG; 100MG | tablet · oral | CADILA PHARMS LTD | Prescription | 18 Sep 2014 |
| HYDRALAZINE HYDROCHLORIDE | 10MG; 25MG; 50MG; 100MG | tablet · oral | SCIEGEN PHARMS | Prescription | 26 May 2017 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | HIKMA | Prescription | 18 Dec 2020 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | EUGIA PHARMA | Prescription | 13 Feb 2023 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | KINDOS | Prescription | 2 Jun 2025 |
| HYDRALAZINE HYDROCHLORIDE | 20MG/ML | injectable · injection | BAXTER HLTHCARE CORP | Prescription | 17 Jul 2025 |
| APRESOLINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | NOVARTIS | Discontinued | 15 Jan 1953 |
| APRESOLINE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | NOVARTIS | Discontinued | 15 Jan 1953 |
| HYDRALAZINE HYDROCHLORIDE | 25MG | tablet · oral | MUTUAL PHARM | Discontinued | 5 Aug 1974 |
| HYDRALAZINE HYDROCHLORIDE | 50MG | tablet · oral | MUTUAL PHARM | Discontinued | 8 Nov 1974 |
| HYDRALAZINE HYDROCHLORIDE | 10MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 8 Sep 1975 |
| HYDRALAZINE HYDROCHLORIDE | 100MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 12 Sep 1975 |
64 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-HYDRALAZINE | 00441619 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-HYDRALAZINE | 00441627 | 25 MG | TABLET · ORAL | APOTEX INC |
| APO-HYDRALAZINE | 00441635 | 50 MG | TABLET · ORAL | APOTEX INC |
| HYDRALAZINE | 02539802 | 10 MG | TABLET · ORAL | SANIS HEALTH INC |
| HYDRALAZINE | 02539810 | 25 MG | TABLET · ORAL | SANIS HEALTH INC |
| HYDRALAZINE | 02539829 | 50 MG | TABLET · ORAL | SANIS HEALTH INC |
| HYDRALAZINE HYDROCHLORIDE INJECTION, USP | 02516160 | 20 MG / ML | SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| HYDRALAZINE HYDROCHLORIDE INJECTION, USP | 02537699 | 20 MG / ML | SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| JAMP-HYDRALAZINE | 02457865 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-HYDRALAZINE | 02457873 | 25 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-HYDRALAZINE | 02457881 | 50 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MINT-HYDRALAZINE | 02468778 | 10 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-HYDRALAZINE | 02468786 | 25 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-HYDRALAZINE | 02468794 | 50 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | HYDRALAZINE 10 MG TABLET | $0.027 | per EA | 23 Sep 2026 |
| US NADAC | HYDRALAZINE 100 MG TABLET | $0.0717 | per EA | 23 Sep 2026 |
| US NADAC | HYDRALAZINE 25 MG TABLET | $0.03572 | per EA | 23 Sep 2026 |
| US NADAC | HYDRALAZINE 50 MG TABLET | $0.04454 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Hydralazine 25mg tablets | £2.81 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Hydralazine 50mg tablets | £3.40 | 56 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 12.3. Antihypertensive medicines · core
Gestational hypertension
Parenteral > General injections > IV: 20 mg in ampoule powder for injection (hydrochloride) | Oral > Solid: 50 mg (hydrochloride); 25 mg (hydrochloride)
Safety signals and safety-related labeling changes
- US FDA 12 Mar 2019 BIDIL — safety-related labeling change
Labeling sections changed: Contraindications; Drug Interactions; Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.