Medicine
Isosorbide dinitrate 5 mg tablet
Isosorbide dinitrate 5 mg tablet is a generic prescription medicine for oral use, made by 10 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). Protect from moisture.
Key facts
- Active ingredient (INN)
- Isosorbide dinitrate
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1000 tablets, 100 tablets, 50 blister pack and 15 more
- Manufacturers
- Zydus LifesciencesIndiaAdvagen PharmaGolden State Medical SupplyHikma PharmaceuticalsPar HealthSandozAvPAKBluePoint LaboratoriesNorthStar RxOceanside Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01DA08 Isosorbide dinitrate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 December 1978
- Identifiers
- RxCUI 206842, 314055, 381056 +2DailyMed set ID 71fdd147-a987-40b6-9f07-82d56525ceb8, 6df6a2fa-c56c-4eb6-a485-c16585420eb0, 0e5842f2-74f6-1f02-01bc-07578bd3b393 +8NDC 0781-1635, 49884-020, 50268-447 +8Application ANDA086221, ANDA086923, ANDA088088 +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 |
|---|---|---|---|
| 1000 tablet in 1 bottle | 70710-1148-0 | Zydus LifesciencesIndia | 25 November 2019 |
| 100 tablet in 1 bottle | 70710-1148-1 | Zydus LifesciencesIndia | 25 November 2019 |
| 1000 tablet in 1 bottle | 70771-1501-0 | Zydus LifesciencesIndia | 25 November 2019 |
| 100 tablet in 1 bottle | 70771-1501-1 | Zydus LifesciencesIndia | 25 November 2019 |
| 1000 tablet in 1 bottle | 72888-081-00 | Advagen Pharma | 8 July 2022 |
| 100 tablet in 1 bottle | 72888-081-01 | Advagen Pharma | 8 July 2022 |
| 100 tablet in 1 bottle, plastic | 0143-1769-01 | Hikma Pharmaceuticals | 1 December 1978 |
| 1000 tablet in 1 bottle, plastic | 0143-1769-10 | Hikma Pharmaceuticals | 1 December 1978 |
| 100 tablet in 1 bottle | 68682-193-01 | Oceanside Pharmaceuticals | 2 March 2020 |
| 100 tablet in 1 bottle | 49884-020-01 | Par Health | 13 December 1979 |
| 1000 tablet in 1 bottle | 49884-020-10 | Par Health | 13 December 1979 |
| 100 tablet in 1 bottle | 0781-1635-01 | Sandoz | 7 January 1988 |
| 1000 tablet in 1 bottle | 0781-1635-10 | Sandoz | 7 January 1988 |
| 50 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 50268-447-15 | AvPAK | 13 September 2016 |
| 100 tablet in 1 bottle, plastic | 68001-373-00 | BluePoint Laboratories | 30 November 2018 |
| 100 tablet in 1 bottle, plastic | 51407-147-01 | Golden State Medical Supply | 17 December 2018 |
| 1000 tablet in 1 bottle, plastic | 51407-147-10 | Golden State Medical Supply | 17 December 2018 |
| 100 tablet in 1 bottle | 16714-007-01 | Northstar Rx | 1 May 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 9 November 1959 | 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 Isosorbide dinitrate
Clinical summary
Isosorbide dinitrate is a nitrate vasodilator indicated for the prevention of angina pectoris due to coronary artery disease. It is available as tablets for oral use. MedsAcross supplies 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 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
- Isosorbide Dinitrate prescribing information (Oceanside Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Isosorbide dinitrate 5 mg tablet for your hospital or patient?
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