Medicine
Baclofen 50 mcg/1 mL injection
Baclofen 50 mcg/1 mL injection is a generic prescription medicine for intrathecal 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
Do not freeze. Store at 20° to 25°C (68° to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Baclofen
- Brand
- Sold under the generic name
- Strength
- 50 mcg/1 mL
- Dosage form
- Injection
- Route
- Intrathecal
- Packs
- 2 syringes of 1 mL
- Manufacturers
- MAlA PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Do not store above 86º F (30º C).
- 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
- 2 April 2021
- Identifiers
- RxCUI 1047437DailyMed set ID ea32c39c-0ee3-4b5e-8da7-4c31db334bd8, e05080ef-53d9-4060-aaa4-86a6935467deNDC 25021-681, 70511-121Application ANDA210777
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 |
|---|---|---|---|
| 2 syringe, glass in 1 carton / 1 mL in 1 syringe, glass | 70511-121-80 | MAlA Pharmaceuticals | 1 June 2022 |
| 2 syringe in 1 carton / 1 mL in 1 syringe | 25021-681-71 | Sagent Pharmaceuticals | 15 July 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 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 50 mcg/1 mL injection.
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 50 mcg/1 mL injection 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.