Medicine
Hydralazine and Isosorbide dinitrate 37.5 mg/20 mg tablet
Hydralazine and Isosorbide dinitrate 37.5 mg/20 mg tablet is a generic prescription medicine for oral use, made by 5 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Protect from…
Key facts
- Active ingredient (INN)
- Hydralazine and Isosorbide dinitrate
- Brand
- Sold under the generic name
- Strength
- 37.5 mg/20 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets, 180 tablets and 5 more
- Manufacturers
- A2A Integrated Pharmaceuticalsi3 PharmaceuticalsIngenus PharmaceuticalsBryant Ranch PrepackWilshire Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 April 2022
- Identifiers
- RxCUI 905377DailyMed set ID cacf1a7c-0388-09ee-e053-2995a90a10cf, 2a6fe05a-fcd4-42d1-bf5d-1d39ac273363, ae757a78-89e8-4f79-81de-d558db3f72a4 +2NDC 72319-012, 72162-2343, 73141-012 +2Application ANDA215988, NDA020727, ANDA215586
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 |
|---|---|---|---|
| 90 tablet, film coated in 1 bottle | 73141-012-03 | A2A Integrated Pharmaceuticals | 22 April 2024 |
| 180 tablet, film coated in 1 bottle | 73141-012-18 | A2A Integrated Pharmaceuticals | 22 April 2024 |
| 90 tablet, film coated in 1 bottle | 72319-012-03 | i3 Pharmaceuticals | 7 February 2024 |
| 180 tablet, film coated in 1 bottle | 72319-012-18 | i3 Pharmaceuticals | 7 February 2024 |
| 180 tablet in 1 bottle | 50742-246-18 | Ingenus Pharmaceuticals | 12 April 2022 |
| 90 tablet in 1 bottle | 50742-246-90 | Ingenus Pharmaceuticals | 12 April 2022 |
| 90 tablet, film coated in 1 bottle | 52536-006-09 | Wilshire Pharmaceuticals | 15 April 2022 |
| 90 tablet, film coated in 1 bottle | 72162-2343-9 | Bryant Ranch Prepack | 1 July 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 23 June 2005 | 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
Alternatives
Other makers and brands of Hydralazine and Isosorbide dinitrate 37.5 mg/20 mg tablet.
Clinical summary
Hydralazine and Isosorbide dinitrate is a fixed-dose combination of an arteriolar vasodilator and a nitrate vasodilator. It is available as tablets for oral use. MedsAcross supplies Hydralazine and Isosorbide dinitrate 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 Hydralazine and Isosorbide dinitrateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BiDil prescribing information (Azurity Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hydralazine and Isosorbide dinitrate 37.5 mg/20 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.