Medicine
Methadone 10 mg/mL oral concentrate
Methadone 10 mg/mL oral concentrate is a generic prescription medicine for oral use, made by 4 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
- 10 mg/mL
- Dosage form
- Oral concentrate
- Route
- Oral
- Packs
- 1000 mL, 1 bottle, 4000 mL and 11 more
- Manufacturers
- Atlantic BiologicalsHikma PharmaceuticalsVistaPharmSpecGx
- 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 Intensol ™ 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
- 6 September 1988
- Identifiers
- RxCUI 991147DailyMed set ID d0e6a966-179a-45e0-8444-4c1b8523f8d2, d7b30c78-c531-4dc5-9552-d68daa3210d1, d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb +2NDC 0054-3553, 17856-0392, 66689-695 +4Application ANDA089897, ANDA040180, ANDA040088 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1000 mL in 1 bottle | 0054-0391-68 | Hikma Pharmaceuticals | 23 June 2010 |
| 1000 mL in 1 bottle | 0054-0392-68 | Hikma Pharmaceuticals | 16 March 2010 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 0054-3553-44 | Hikma Pharmaceuticals | 6 September 1988 |
| 1000 mL in 1 bottle | 66689-694-79 | VistaPharm | 30 October 2009 |
| 4000 mL in 1 bottle | 66689-694-88 | VistaPharm | 19 August 2024 |
| 1000 mL in 1 bottle | 66689-695-79 | VistaPharm | 29 March 2017 |
| 1 bottle, dropper in 1 carton / 30 mL in 1 bottle, dropper | 0406-4123-03 | SpecGx | 18 June 2021 |
| 1000 mL in 1 bottle | 0406-4123-10 | SpecGx | 18 June 2021 |
| 60 syringe in 1 box, unit-dose / .5 mL in 1 syringe | 17856-0392-1 | Atlantic Biologicals | 20 May 2024 |
| 72 cup, unit-dose in 1 box, unit-dose / 2.5 mL in 1 cup, unit-dose | 17856-0392-3 | Atlantic Biologicals | 20 May 2024 |
| 1 syringe in 1 bag / .5 mL in 1 syringe | 17856-0392-6 | Atlantic Biologicals | 30 May 2025 |
| 5 box, unit-dose in 1 syringe / 60 syringe in 1 box, unit-dose / 1 mL in 1 syringe | 17856-0392-7 | Atlantic Biologicals | 20 May 2024 |
| 1 syringe in 1 bag / 1 mL in 1 syringe | 17856-0392-8 | Atlantic Biologicals | 30 May 2025 |
| 1 syringe in 1 bag / 2.5 mL in 1 syringe | 17856-0392-9 | Atlantic Biologicals | 30 May 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 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
Alternatives
Other makers and brands of Methadone 10 mg/mL oral concentrate.
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/mL oral concentrate 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.