Medicine
Hydralazine 20 mg/1 mL injection
Hydralazine 20 mg/1 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 14 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Hydralazine
- Brand
- Sold under the generic name
- Strength
- 20 mg/1 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 vials of 1 mL, 1 mL, 25 pouches of 1 mL and 20 more
- Manufacturers
- EugiaIndiaZydus LifesciencesIndiaFresenius KabiHealthFirstMedical Purchasing SolutionsCardinal HealthAmerican RegentBaxter HealthcareCivicaHenry Schein
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C02DB02 Hydralazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 June 1997
- Identifiers
- RxCUI 966571DailyMed set ID 3855c3da-ff25-8301-e063-6294a90a22b3, 9949407f-e410-7f47-e053-2995a90a7369, f0db9c3c-d841-46f9-8409-9ffca83d7a97 +19NDC 84549-614, 51662-1376, 70710-1988 +16Application ANDA040388, ANDA202938, ANDA040730 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 55150-400-25 | EugiaIndia | 13 February 2023 |
| 25 vial in 1 package / 1 mL in 1 vial | 70710-1988-7 | Zydus LifesciencesIndia | 28 April 2025 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 63323-614-01 | Fresenius Kabi | 5 September 2001 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 63323-614-06 | Fresenius Kabi | 5 September 2001 |
| 25 vial, single-use in 1 tray / 1 mL in 1 vial, single-use | 63323-614-16 | Fresenius Kabi | 5 September 2001 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 63323-614-55 | Fresenius Kabi | 31 January 2011 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 0517-0901-25 | American Regent | 30 June 1997 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 43066-041-25 | Baxter Healthcare | 17 July 2025 |
| 25 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose | 71288-205-02 | Meitheal Pharmaceuticals | 2 June 2025 |
| 25 vial in 1 package / 1 mL in 1 vial | 68475-514-02 | Navinta | 25 November 2025 |
| 1 mL in 1 vial, single-dose | 51662-1376-1 | HealthFirst | 9 December 2019 |
| 25 pouch in 1 box / 1 vial, single-dose in 1 pouch / 1 mL in 1 vial, single-dose | 51662-1376-3 | HealthFirst | 11 May 2021 |
| 1 mL in 1 vial, single-dose | 51662-1388-1 | HealthFirst | 7 October 2019 |
| 25 pouch in 1 case / 1 vial, single-dose in 1 pouch / 1 mL in 1 vial, single-dose | 51662-1648-3 | HealthFirst | 30 June 1997 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7145-1 | Medical Purchasing Solutions | 4 October 2018 |
| 1 vial, single-use in 1 bag / 1 mL in 1 vial, single-use | 71872-7268-1 | Medical Purchasing Solutions | 11 October 2001 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 71872-7339-1 | Medical Purchasing Solutions | 26 December 2024 |
| 5 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 55154-9554-5 | Cardinal Health | 5 September 2001 |
| 5 vial, single-use in 1 bag / 1 mL in 1 vial, single-use | 55154-9587-5 | Cardinal Health | 31 October 2024 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 72572-265-25 | Civica | 29 October 2020 |
| 1 vial, single-dose in 1 bag / 1 mL in 1 vial, single-dose | 0404-9787-01 | Henry Schein | 10 April 2025 |
| 1 mL in 1 vial, single-dose | 84549-614-55 | ProPharma Distribution | 27 August 2025 |
| 25 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 70518-3659-1 | Remedyrepack | 19 September 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 15 January 1953 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Hydralazine
Clinical summary
Hydralazine is an arteriolar vasodilator. It is available as tablets and injection for oral, intramuscular and intravenous use. MedsAcross supplies Hydralazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about HydralazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hydralazine Hydrochloride prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Hydralazine 20 mg/1 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.