Medicine
BiDil 37.5 mg/20 mg tablet
BiDil 37.5 mg/20 mg tablet is a prescription medicine containing Hydralazine and Isosorbide dinitrate for oral use, marketed by Azurity Pharmaceuticals, 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
- BiDil
- Strength
- 37.5 mg/20 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets
- Marketing authorisation holder
- Azurity Pharmaceuticals
- Manufacturer
- Azurity 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
- 5 December 2012
- Identifiers
- RxCUI 905377, 905379DailyMed set ID e1e63cd5-d1e4-4af5-bad5-1ad41ea46b00NDC 24338-010Application NDA020727
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 tablet, film coated in 1 bottle | 24338-010-09 | Azurity Pharmaceuticals | 31 August 2020 |
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 BiDil 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.