Medicine
Nitrolingual 400 mcg oral spray
Nitrolingual 400 mcg oral spray is a prescription medicine containing Nitroglycerin for oral use, marketed by Independence 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 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C - 30°C (59°F…
Key facts
- Active ingredient (INN)
- Nitroglycerin
- Brand
- Nitrolingual
- Strength
- 400 mcg
- Dosage form
- Oral spray
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Independence Pharmaceuticals
- Manufacturer
- Independence Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C - 30°C (59°F - 86°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
- 2 December 2024
- Identifiers
- RxCUI 705129, 995019DailyMed set ID d19b5f51-ca85-48d6-9ccd-8ae26249cdc3NDC 21724-100Application NDA018705
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, spray in 1 carton / 200 spray in 1 bottle, spray | 21724-100-41 | Independence Pharmaceuticals | 2 December 2024 |
| 1 bottle, spray in 1 carton / 60 spray in 1 bottle, spray | 21724-100-50 | Independence Pharmaceuticals | 2 December 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 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 400 mcg oral spray.
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 Nitrolingual 400 mcg oral spray 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.