Medicine
Metaxalone 400 mg tablet
Metaxalone 400 mg tablet is a generic prescription medicine for oral use, made by 6 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)
- Metaxalone
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 4 more
- Manufacturers
- CiplaIndiaScieGen PharmaceuticalsAmneal Pharmaceuticals of New YorkBlue Heron PharmaceuticalsHighmark PharmaMisemer 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 May 2016
- Identifiers
- RxCUI 197935, 351254DailyMed set ID de3448df-4ca1-44ec-bad1-486549cddf64, d0276e7b-a1c9-61f3-e053-2a95a90ae3aa, 1cef46bb-e590-4a58-82e0-7cf1fc3836a5 +3NDC 0115-1745, 0276-0508, 50228-474 +3Application ANDA040486, ANDA207466
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 69097-998-07 | CiplaIndia | 12 June 2023 |
| 100 tablet in 1 bottle | 0115-1745-01 | Amneal Pharmaceuticals of New York | 26 May 2016 |
| 100 tablet in 1 bottle | 85622-950-10 | Blue Heron Pharmaceuticals | 15 September 2026 |
| 100 tablet in 1 bottle | 87450-101-10 | Highmark Pharma | 26 April 2026 |
| 100 tablet in 1 bottle | 0276-0508-10 | Misemer Pharmaceuticals | 1 November 2021 |
| 1000 tablet in 1 bottle | 50228-474-10 | ScieGen Pharmaceuticals | 30 April 2020 |
| 30 tablet in 1 bottle | 50228-474-30 | ScieGen Pharmaceuticals | 30 April 2020 |
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 13 August 1962 | 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 Metaxalone
Clinical summary
Metaxalone is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults, among other approved uses. MedsAcross supplies Metaxalone 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 MetaxaloneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Metaxalone prescribing information (INA Pharmaceutics) · U.S. National Library of Medicine, DailyMed
Need Metaxalone 400 mg 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.