Medicine
Nitrostat 0.4 mg sublingual tablet
Nitrostat 0.4 mg sublingual tablet is a prescription medicine containing Nitroglycerin for sublingual use, marketed by Viatris Specialty, 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 Controlled Room Temperature 20°25°C (68°77°F).
Key facts
- Active ingredient (INN)
- Nitroglycerin
- Brand
- Nitrostat
- Strength
- 0.4 mg
- Dosage form
- Sublingual tablet
- Route
- Sublingual
- Packs
- 1 bottle, 4 bottles, 25 tablets and 2 more
- Marketing authorisation holder
- Viatris Specialty
- Manufacturers
- Viatris SpecialtyA-S Medication SolutionsHenry ScheinProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store at Controlled Room Temperature 20°25°C (68°77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01DA02 Nitroglycerin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 2000
- Identifiers
- RxCUI 198039, 207346, 198038 +3DailyMed set ID f7059ff7-bf74-48b4-811d-6eb1c26bfd8b, 5265648f-3062-48a2-a4e3-fea1207807a8, 6fe3965f-0dd8-4bae-9771-de25074cb1b0 +1NDC 50090-7203, 0404-9800, 63187-884 +1Application NDA021134
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 100 tablet in 1 bottle | 58151-310-01 | Viatris Specialty | 2 February 2024 |
| 4 bottle in 1 carton / 25 tablet in 1 bottle | 58151-310-52 | Viatris Specialty | 2 February 2024 |
| 1 bottle in 1 carton / 25 tablet in 1 bottle | 50090-7203-0 | A-S Medication Solutions | 1 August 2024 |
| 1 bottle in 1 bag / 25 tablet in 1 bottle | 0404-9800-01 | Henry Schein | 17 September 2024 |
| 25 tablet in 1 bottle | 63187-884-25 | Proficient Rx | 2 October 2017 |
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 September 1981 | 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 Nitroglycerin 0.4 mg sublingual tablet.
Other strengths and forms of Nitroglycerin
Clinical summary
Nitroglycerin is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. It is available as sublingual tablets, transdermal patches and ointment for intravenous use. MedsAcross supplies Nitroglycerin 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 NitroglycerinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- NITROGLYCERIN LINGUAL prescribing information (Allegis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Nitrostat 0.4 mg sublingual 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.