Medicine
Methadone 10 mg/5 mL oral solution
Methadone 10 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 2 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). Store methadone hydrochloride oral…
Key facts
- Active ingredient (INN)
- Methadone
- Brand
- Sold under the generic name
- Strength
- 10 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 500 mL
- Manufacturers
- Hikma PharmaceuticalsSpecGx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Store methadone hydrochloride oral solution 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
- 30 August 1982
- Identifiers
- RxCUI 864761, 864769DailyMed set ID 5baef1bf-8bf0-429c-a4ce-1c93171f3f15, 8c363f90-c378-48ae-abbc-aeb25c9bf5cbNDC 0406-6221, 0054-3556Application ANDA207537, ANDA087997
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 |
|---|---|---|---|
| 500 mL in 1 bottle | 0054-3556-63 | Hikma Pharmaceuticals | 30 August 1982 |
| 500 mL in 1 bottle | 0406-6221-05 | SpecGx | 18 June 2021 |
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 10 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.