Medicine
Hydralazine 100 mg tablet
Hydralazine 100 mg tablet is a generic prescription medicine for oral use, made by 20 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°-25°C (68°-77°F).
Key facts
- Active ingredient (INN)
- Hydralazine
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 39 more
- Manufacturers
- Macleods PharmaceuticalsIndiaStrides PharmaIndiaAscend LaboratoriesIndiaCadila PharmaceuticalsIndiaCamber PharmaceuticalsIndiaAvet PharmaceuticalsIndiaBryant Ranch PrepackAphena Pharma Solutions - TennesseeModavar PharmaceuticalsRemedyrepack20 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-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 September 1990
- Identifiers
- RxCUI 905222, 905225, 905199 +1DailyMed set ID d2d98842-ff32-4a61-94e0-60e06919948f, f9f56326-6d72-47d3-89ac-3625b8a6d713, 921c8693-84c2-4313-a2a6-ab3be637d554 +22NDC 71335-1589, 33342-377, 43353-205 +22Application ANDA040901, ANDA211010, ANDA090255 +7
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
A sample of 40 packs from 20 labelers. The register lists 42 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 67877-290-01 | Ascend LaboratoriesIndia | 24 May 2010 |
| 500 tablet in 1 bottle | 67877-290-05 | Ascend LaboratoriesIndia | 24 May 2010 |
| 100 tablet in 1 bottle | 23155-835-01 | Avet PharmaceuticalsIndia | 2 August 2023 |
| 100 tablet in 1 bottle | 71209-018-05 | Cadila PharmaceuticalsIndia | 29 December 2015 |
| 1000 tablet in 1 bottle | 71209-018-11 | Cadila PharmaceuticalsIndia | 29 December 2015 |
| 100 tablet in 1 bottle | 31722-522-01 | Camber PharmaceuticalsIndia | 1 January 2010 |
| 500 tablet in 1 bottle | 31722-522-05 | Camber PharmaceuticalsIndia | 1 January 2010 |
| 100 tablet in 1 bottle | 33342-377-11 | Macleods PharmaceuticalsIndia | 26 August 2024 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-377-12 | Macleods PharmaceuticalsIndia | 26 August 2024 |
| 1000 tablet in 1 bottle | 33342-377-44 | Macleods PharmaceuticalsIndia | 26 August 2024 |
| 100 tablet in 1 bottle | 64380-736-06 | Strides PharmaIndia | 30 June 2013 |
| 500 tablet in 1 bottle | 64380-736-07 | Strides PharmaIndia | 30 June 2013 |
| 1000 tablet in 1 bottle | 64380-736-08 | Strides PharmaIndia | 30 June 2013 |
| 120 tablet, film coated in 1 bottle | 62135-582-12 | Chartwell RX | 9 May 2023 |
| 100 tablet in 1 bottle | 76282-312-01 | Exelan Pharmaceuticals | 20 May 2016 |
| 100 tablet in 1 bottle | 72241-006-05 | Modavar Pharmaceuticals | 29 December 2015 |
| 1000 tablet in 1 bottle | 72241-006-11 | Modavar Pharmaceuticals | 29 December 2015 |
| 100 tablet in 1 bottle | 77771-185-01 | Radha Pharmaceuticals | 4 March 2021 |
| 100 tablet in 1 bottle | 50228-185-01 | ScieGen Pharmaceuticals | 26 May 2017 |
| 1000 tablet in 1 bottle | 50228-185-10 | ScieGen Pharmaceuticals | 26 May 2017 |
| 100 tablet in 1 bottle | 50111-397-01 | Teva Pharmaceuticals | 30 September 1990 |
| 100 tablet in 1 bottle | 63629-8495-1 | Bryant Ranch Prepack | 18 May 2021 |
| 30 tablet in 1 bottle | 71335-1589-1 | Bryant Ranch Prepack | 12 September 2014 |
| 60 tablet in 1 bottle | 71335-1589-2 | Bryant Ranch Prepack | 12 September 2014 |
| 90 tablet in 1 bottle | 71335-1589-3 | Bryant Ranch Prepack | 12 September 2014 |
| 100 tablet in 1 bottle | 71335-1589-4 | Bryant Ranch Prepack | 12 September 2014 |
| 30 tablet in 1 bottle | 71335-9722-1 | Bryant Ranch Prepack | 30 May 2023 |
| 60 tablet in 1 bottle | 71335-9722-2 | Bryant Ranch Prepack | 30 May 2023 |
| 90 tablet in 1 bottle | 71335-9722-3 | Bryant Ranch Prepack | 30 May 2023 |
| 100 tablet in 1 bottle | 72162-1538-1 | Bryant Ranch Prepack | 5 February 2024 |
| 4200 tablet in 1 bottle | 43353-124-05 | Aphena Pharma Solutions - Tennessee | 2 December 2015 |
| 4200 tablet in 1 bottle | 43353-205-05 | Aphena Pharma Solutions - Tennessee | 9 July 2016 |
| 2000 tablet in 1 bottle | 71610-549-02 | Aphena Pharma Solutions - Tennessee | 1 April 2024 |
| 4200 tablet in 1 bottle | 71610-549-05 | Aphena Pharma Solutions - Tennessee | 30 April 2021 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7450-61 | Major Pharmaceuticals | 3 January 2025 |
| 100 tablet in 1 bottle | 68071-5285-1 | NuCare Pharmaceuticals,Inc | 18 June 2020 |
| 100 tablet in 1 bottle | 68788-8087-1 | Preferred Pharmaceuticals | 5 October 2021 |
| 30 tablet in 1 bottle | 82804-197-30 | Proficient Rx | 19 February 2025 |
| 90 tablet in 1 bottle, plastic | 70518-4352-0 | Remedyrepack | 3 June 2025 |
| 30 tablet in 1 blister pack | 70518-4352-1 | Remedyrepack | 19 June 2025 |
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 100 mg tablet 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.