Medicine
Metaxalone 800 mg tablet
Metaxalone 800 mg tablet is a generic prescription medicine for oral use, made by 28 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 20º C to 25º C (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Metaxalone
- Brand
- Sold under the generic name
- Strength
- 800 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 20 tablets, 30 tablets and 183 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaBryant Ranch PrepackDoc RxAmneal Pharmaceuticals of New YorkScieGen PharmaceuticalsAmneal PharmaceuticalsLannettActavis Pharma28 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20º C to 25º C (68º to 77ºF).
- 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
- 31 May 2013
- Identifiers
- RxCUI 351254, 197935DailyMed set ID a662fd07-2896-4cbb-bafc-aa5ab179a148, 8294bb3c-c8eb-474c-b567-e53cf81249e9, b713a0f2-d47a-0ae7-e053-2995a90a5b85 +37NDC 71335-2066, 0527-1435, 80425-0122 +37Application ANDA204770, ANDA207466, ANDA203695 +1
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
A sample of 40 packs from 28 labelers. The register lists 186 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 55111-650-01 | Dr. Reddy's LaboratoriesIndia | 31 August 2017 |
| 100 tablet in 1 bottle | 69306-100-01 | Doc Rx | 1 April 2019 |
| 20 tablet in 1 bottle | 69306-100-02 | Doc Rx | 1 January 2020 |
| 30 tablet in 1 bottle | 69306-100-03 | Doc Rx | 13 December 2019 |
| 60 tablet in 1 bottle | 69306-100-06 | Doc Rx | 13 December 2019 |
| 90 tablet in 1 bottle | 69306-100-09 | Doc Rx | 13 December 2019 |
| 15 tablet in 1 bottle | 69306-100-15 | Doc Rx | 1 January 2020 |
| 20 tablet in 1 bottle | 69306-311-20 | Doc Rx | 25 March 2022 |
| 30 tablet in 1 bottle | 69306-311-30 | Doc Rx | 25 March 2022 |
| 60 tablet in 1 bottle | 69306-311-60 | Doc Rx | 25 March 2022 |
| 90 tablet in 1 bottle | 69306-311-90 | Doc Rx | 25 March 2022 |
| 100 tablet in 1 bottle | 0591-2341-01 | Actavis Pharma | 19 June 2017 |
| 100 tablet in 1 bottle | 65162-553-10 | Amneal Pharmaceuticals | 31 May 2013 |
| 500 tablet in 1 bottle | 65162-553-50 | Amneal Pharmaceuticals | 31 May 2013 |
| 100 tablet in 1 bottle | 53746-553-01 | Amneal Pharmaceuticals of New York | 31 May 2013 |
| 500 tablet in 1 bottle | 53746-553-05 | Amneal Pharmaceuticals of New York | 31 May 2013 |
| 30 tablet in 1 bottle | 53746-553-30 | Amneal Pharmaceuticals of New York | 31 May 2013 |
| 100 tablet in 1 bottle | 0527-1435-01 | Lannett | 22 November 2016 |
| 500 tablet in 1 bottle | 0527-1435-05 | Lannett | 22 November 2016 |
| 100 tablet in 1 bottle | 50228-323-01 | ScieGen Pharmaceuticals | 31 August 2017 |
| 500 tablet in 1 bottle | 50228-323-05 | ScieGen Pharmaceuticals | 31 August 2017 |
| 30 tablet in 1 bottle | 50228-323-30 | ScieGen Pharmaceuticals | 31 August 2017 |
| 100 tablet in 1 bottle | 63629-2097-1 | Bryant Ranch Prepack | 22 November 2016 |
| 30 tablet in 1 bottle | 63629-8014-1 | Bryant Ranch Prepack | 18 June 2019 |
| 90 tablet in 1 bottle | 63629-8014-2 | Bryant Ranch Prepack | 2 October 2019 |
| 100 tablet in 1 bottle | 63629-8014-3 | Bryant Ranch Prepack | 26 December 2019 |
| 60 tablet in 1 bottle | 63629-8014-4 | Bryant Ranch Prepack | 22 October 2019 |
| 10 tablet in 1 bottle | 63629-8014-5 | Bryant Ranch Prepack | 14 January 2020 |
| 20 tablet in 1 bottle | 63629-8014-6 | Bryant Ranch Prepack | 28 February 2020 |
| 120 tablet in 1 bottle | 63629-8014-7 | Bryant Ranch Prepack | 11 April 2024 |
| 15 tablet in 1 bottle | 63629-8014-8 | Bryant Ranch Prepack | 11 April 2024 |
| 100 tablet in 1 bottle | 71335-0375-0 | Bryant Ranch Prepack | 30 November 2018 |
| 30 tablet in 1 bottle | 71335-0375-1 | Bryant Ranch Prepack | 30 November 2018 |
| 20 tablet in 1 bottle | 71335-0375-2 | Bryant Ranch Prepack | 30 November 2018 |
| 90 tablet in 1 bottle | 71335-0375-3 | Bryant Ranch Prepack | 30 November 2018 |
| 120 tablet in 1 bottle | 71335-0375-4 | Bryant Ranch Prepack | 30 November 2018 |
| 15 tablet in 1 bottle | 71335-0375-5 | Bryant Ranch Prepack | 30 November 2018 |
| 10 tablet in 1 bottle | 71335-0375-6 | Bryant Ranch Prepack | 30 November 2018 |
| 60 tablet in 1 bottle | 71335-0375-7 | Bryant Ranch Prepack | 30 November 2018 |
| 16 tablet in 1 bottle | 71335-0375-8 | Bryant Ranch Prepack | 30 November 2018 |
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 800 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.