Medicine
Ontralfy 2 mg/5 mL oral solution
Ontralfy 2 mg/5 mL oral solution is a prescription medicine containing Tizanidine for oral use, marketed by Rosemont 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 to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Tizanidine
- Brand
- Ontralfy
- Strength
- 2 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL
- Marketing authorisation holder
- Rosemont Pharmaceuticals
- Manufacturer
- Rosemont Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M03BX02 Tizanidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 March 2025
- Identifiers
- RxCUI 2709432, 2709438DailyMed set ID 7b88c338-c0b7-4c08-bef6-a4ffc2f25df7NDC 69528-310Application NDA216190
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 |
|---|---|---|---|
| 473 mL in 1 bottle, plastic | 69528-310-16 | Rosemont Pharmaceuticals | 1 October 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 27 November 1996 | 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 Tizanidine
Clinical summary
Tizanidine is a central alpha-2 adrenergic agonist indicated for the treatment of spasticity in adults. It is available as tablets, capsules and oral solution. MedsAcross supplies Tizanidine 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 TizanidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zanaflex prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
Need Ontralfy 2 mg/5 mL oral solution 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.