Medicine
Isosorbide mononitrate 120 mg extended-release tablet
Isosorbide mononitrate 120 mg extended-release tablet is a generic prescription medicine for oral use, made by 8 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 30°C (68° to 86°F).
Key facts
- Active ingredient (INN)
- Isosorbide mononitrate
- Brand
- Sold under the generic name
- Strength
- 120 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 90 tablets and 7 more
- Manufacturers
- Torrent PharmaceuticalsIndiaAurobindo PharmaIndiaShandong New Time PharmaceuticalAiPing PharmaceuticalChartwell RXEdenbridge PharmaceuticalsGolden State Medical SupplyIngenus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 30°C (68° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01DA14 Isosorbide mononitrate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 June 2011
- Identifiers
- RxCUI 311196, 317110, 353538DailyMed set ID 21bd9824-537d-4bcd-8093-1270df52c29c, cd953cfa-b6f5-4b82-afcc-52a57236b9d3, 7443a5b6-6153-4227-870c-3c710f1f2174 +5NDC 11788-161, 42677-307, 42799-960 +5Application ANDA214115, ANDA210822, ANDA216557 +2
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 |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 59651-541-01 | Aurobindo PharmaIndia | 7 November 2022 |
| 100 tablet, extended release in 1 bottle | 13668-106-01 | Torrent PharmaceuticalsIndia | 3 June 2011 |
| 1000 tablet, extended release in 1 bottle | 13668-106-10 | Torrent PharmaceuticalsIndia | 3 June 2011 |
| 100 tablet, extended release in 1 bottle | 11788-161-01 | AiPing Pharmaceutical | 30 October 2026 |
| 90 tablet, extended release in 1 bottle | 62135-588-90 | Chartwell RX | 26 April 2023 |
| 100 tablet, extended release in 1 bottle | 42799-960-01 | Edenbridge Pharmaceuticals | 1 July 2023 |
| 100 tablet, extended release in 1 bottle, plastic | 50742-177-01 | Ingenus Pharmaceuticals | 13 November 2018 |
| 60 tablet, extended release in 1 bottle, plastic | 42677-307-01 | Shandong New Time Pharmaceutical | 29 April 2022 |
| 600 tablet, extended release in 1 bottle, plastic | 42677-307-02 | Shandong New Time Pharmaceutical | 29 April 2022 |
| 100 tablet, extended release in 1 bottle, plastic | 51407-210-01 | Golden State Medical Supply | 19 April 2019 |
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 30 December 1991 | 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 mononitrate
Clinical summary
Isosorbide mononitrate is a nitrate vasodilator indicated for the prevention and treatment of angina pectoris due to coronary artery disease. It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Isosorbide mononitrate 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 mononitrateFor 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 mononitrate prescribing information (Omnivium Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Isosorbide mononitrate 120 mg extended-release 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.