Medicine
Tonmya 2.8 mg orally disintegrating tablet
Tonmya 2.8 mg orally disintegrating tablet is a prescription medicine containing Cyclobenzaprine for sublingual use, marketed by Tonix Medicines, 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 and dispense in original container and protect from moisture.
Key facts
- Active ingredient (INN)
- Cyclobenzaprine
- Brand
- Tonmya
- Strength
- 2.8 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Sublingual
- Packs
- 14 tablets, 30 tablets, 60 tablets and 1 more
- Marketing authorisation holder
- Tonix Medicines
- Manufacturer
- Tonix Medicines
- Origin register
- US FDA, United States
- Storage
- Store and dispense in original container and protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M03BX08 Cyclobenzaprine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 August 2025
- Identifiers
- RxCUI 2723106, 2723114DailyMed set ID 6fa59588-ce9b-48cf-8c5f-725a448f8571NDC 70792-102Application NDA219428
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 |
|---|---|---|---|
| 14 tablet, orally disintegrating in 1 bottle | 70792-102-14 | Tonix Medicines | 15 September 2025 |
| 30 tablet, orally disintegrating in 1 bottle | 70792-102-30 | Tonix Medicines | 23 October 2025 |
| 60 tablet, orally disintegrating in 1 bottle | 70792-102-60 | Tonix Medicines | 15 September 2025 |
| 90 tablet, orally disintegrating in 1 bottle | 70792-102-90 | Tonix Medicines | 15 September 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 26 August 1977 | 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 Cyclobenzaprine
Clinical summary
Cyclobenzaprine is a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. MedsAcross supplies Cyclobenzaprine 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 CyclobenzaprineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cyclobenzaprine Hydrochloride prescribing information (Amneal Pharmaceuticals of New York) · U.S. National Library of Medicine, DailyMed
Need Tonmya 2.8 mg orally disintegrating 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.