Medicine
Methadone 5 mg tablet
Methadone 5 mg tablet is a generic prescription medicine for oral use, made by 8 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), with excursions permitted between 15° to…
Key facts
- Active ingredient (INN)
- Methadone
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1000 tablets and 10 more
- Manufacturers
- Aurolife PharmaIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaSpecGxHikma PharmaceuticalsElite LaboratoriesEpic PharmaXLCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F). Store methadone hydrochloride tablets securely and dispose of properly.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CII
- ATC code
- N07BC02 Methadone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 March 1983
- Identifiers
- RxCUI 864706, 864718DailyMed set ID 6da7501b-b881-4bc7-891a-74214a00a3ac, f0366917-f745-4b01-a662-a98a7d80b4a0, 50f14803-78c0-4d19-8b5d-9a9c17582ac1 +5NDC 42806-317, 67877-659, 0054-0709 +5Application ANDA090065, ANDA090635, ANDA088109 +4
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 | 67877-659-01 | Ascend LaboratoriesIndia | 1 July 2025 |
| 100 tablet in 1 bottle | 13107-088-01 | Aurolife PharmaIndia | 15 September 2015 |
| 30 tablet in 1 bottle | 13107-088-30 | Aurolife PharmaIndia | 15 September 2015 |
| 1000 tablet in 1 bottle | 13107-088-99 | Aurolife PharmaIndia | 15 September 2015 |
| 100 tablet in 1 bottle | 31722-946-01 | Camber PharmaceuticalsIndia | 3 January 2019 |
| 100 tablet in 1 bottle, plastic | 64850-603-01 | Elite Laboratories | 6 August 2018 |
| 100 tablet in 1 bottle | 42806-317-01 | Epic Pharma | 11 June 2018 |
| 1 blister pack in 1 carton / 100 tablet in 1 blister pack | 0054-0709-20 | Hikma Pharmaceuticals | 8 March 1983 |
| 100 tablet in 1 bottle, plastic | 0054-0709-25 | Hikma Pharmaceuticals | 8 March 1983 |
| 100 tablet in 1 bottle | 0406-5755-01 | SpecGx | 27 April 2004 |
| 1 tablet in 1 blister pack | 0406-5755-23 | SpecGx | 27 April 2004 |
| 100 tablet in 1 blister pack | 0406-5755-62 | SpecGx | 27 April 2004 |
| 100 tablet in 1 bottle | 72865-120-01 | XLCare Pharmaceuticals | 3 January 2019 |
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 1947 | 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 Methadone
Clinical summary
Methadone is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids, among other approved uses. MedsAcross supplies Methadone 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 MethadoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Methadone Hydrochloride prescribing information (Mylan Institutional) · U.S. National Library of Medicine, DailyMed
Need Methadone 5 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.