Medicine
Baclofen 10 mg/5 mL oral solution
Baclofen 10 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 5 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 to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Baclofen
- Brand
- Sold under the generic name
- Strength
- 10 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 40 cup, 473 mL, 237 mL and 9 more
- Manufacturers
- Atlantic BiologicalsAcella PharmaceuticalsAdvagen PharmaPalmetto PharmaceuticalsTruPharma
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- M03BX01 Baclofen
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 October 2023
- Identifiers
- RxCUI 2667941DailyMed set ID 75ab298b-b2a7-458f-accc-5bfc89b89a16, 50b3e7be-832b-313d-e063-6394a90a5ab4, f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7 +2NDC 72888-466, 17856-0620, 52817-620 +2Application ANDA214445, NDA208193
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 |
|---|---|---|---|
| 40 cup, unit-dose in 1 case / 10 mL in 1 cup, unit-dose | 42192-631-40 | Acella Pharmaceuticals | 26 October 2026 |
| 40 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 42192-631-45 | Acella Pharmaceuticals | 26 October 2026 |
| 473 mL in 1 bottle | 72888-466-01 | Advagen Pharma | 3 June 2025 |
| 237 mL in 1 bottle | 72888-466-02 | Advagen Pharma | 3 June 2025 |
| 473 mL in 1 bottle | 68134-403-16 | Palmetto Pharmaceuticals | 25 September 2024 |
| 237 mL in 1 bottle | 52817-620-08 | Trupharma | 12 October 2023 |
| 72 cup, unit-dose in 1 case / 2.5 mL in 1 cup, unit-dose | 17856-0620-1 | Atlantic Biologicals | 30 April 2026 |
| 72 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 17856-0620-2 | Atlantic Biologicals | 30 April 2026 |
| 1 syringe in 1 bag / 2.5 mL in 1 syringe | 17856-0620-3 | Atlantic Biologicals | 14 July 2026 |
| 1 syringe in 1 bag / 5 mL in 1 syringe | 17856-0620-4 | Atlantic Biologicals | 14 July 2026 |
| 45 syringe in 1 box, unit-dose / 5 mL in 1 syringe | 17856-0620-5 | Atlantic Biologicals | 4 September 2026 |
| 90 syringe in 1 box, unit-dose / 2.5 mL in 1 syringe | 17856-0620-9 | Atlantic Biologicals | 4 September 2026 |
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 22 November 1977 | 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 Baclofen 10 mg/5 mL oral solution.
Other strengths and forms of Baclofen
Clinical summary
Baclofen is a gamma-aminobutyric acid-ergic agonist indicated in the management of severe spasticity. It is available as tablets, injection and oral solution for intrathecal use. MedsAcross supplies Baclofen 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 BaclofenFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lioresal (baclofen) prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Baclofen 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.