Medicine
Zolmitriptan 5 mg nasal spray
Zolmitriptan 5 mg nasal spray is a generic prescription medicine for nasal use, made by 3 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).
Key facts
- Active ingredient (INN)
- Zolmitriptan
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Nasal spray
- Route
- Nasal
- Packs
- 6 bottles and 2 more
- Manufacturers
- Bryant Ranch PrepackAmneal Pharmaceuticals NYPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N02CC03 Zolmitriptan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 November 2021
- Identifiers
- RxCUI 402000, 1483677DailyMed set ID e304c986-24fa-451e-a560-0af658ba387b, 8b4e77de-3185-4d1e-946a-96b785b76da0, 05a40502-149d-41bd-966e-771e937a955b +2NDC 72162-1425, 63629-9575, 69238-2352 +2Application ANDA212469, NDA021450
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 |
|---|---|---|---|
| 6 bottle, spray in 1 carton / 1 spray, metered in 1 bottle, spray | 69238-2352-6 | Amneal Pharmaceuticals NY | 15 July 2024 |
| 6 bottle, spray in 1 carton / 1 spray in 1 bottle, spray | 45802-711-91 | Padagis Israel Pharmaceuticals | 16 November 2021 |
| 6 bottle, spray in 1 carton / 1 spray in 1 bottle, spray | 63629-9575-1 | Bryant Ranch Prepack | 21 December 2022 |
| 6 bottle, spray in 1 carton / 1 spray in 1 bottle, spray | 71335-2947-1 | Bryant Ranch Prepack | 28 October 2025 |
| 6 bottle, spray in 1 carton / 1 spray in 1 bottle, spray | 72162-1425-2 | Bryant Ranch Prepack | 3 April 2025 |
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 25 November 1997 | 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 Zolmitriptan
Clinical summary
Zolmitriptan is a serotonin-1b and serotonin-1d receptor agonist indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older, among other approved uses. MedsAcross supplies Zolmitriptan 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 ZolmitriptanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zolmitriptan prescribing information (Amneal Pharmaceuticals NY) · U.S. National Library of Medicine, DailyMed
Need Zolmitriptan 5 mg nasal 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.