Baclofen 5 mg tablet is a generic prescription medicine for oral use, made by 23 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).
Key facts
- Active ingredient (INN)
- Baclofen
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 10 blister pack and 35 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndiaLifestar PharmaIndiaUnichem LaboratoriesIndiaAsclemedBryant Ranch PrepackMethod PharmaceuticalsEywa PharmaAdvagen PharmaPD-Rx Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 1 April 2018
- Identifiers
- RxCUI 430902, 197391, 197392 +1DailyMed set ID 3c87e116-871d-46b8-897b-fc27a17b988d, f9dd1b55-2984-446a-8146-2ab0f5211e15, 43cafbdb-6927-45f6-9b16-3b125cc2a29d +24NDC 55154-4349, 70756-085, 72162-2372 +25Application ANDA211659, ANDA215885, ANDA212378 +6
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 | 70710-1609-1 | Zydus LifesciencesIndia | 7 May 2020 |
| 100 tablet in 1 bottle | 70771-1586-1 | Zydus LifesciencesIndia | 7 May 2020 |
| 100 tablet in 1 bottle | 84386-035-01 | Aurobindo PharmaIndia | 21 November 2025 |
| 100 tablet in 1 bottle | 70756-085-11 | Lifestar PharmaIndia | 26 January 2022 |
| 100 tablet in 1 bottle | 29300-474-01 | Unichem LaboratoriesIndia | 15 June 2023 |
| 100 tablet in 1 bottle | 58657-730-01 | Method Pharmaceuticals | 15 June 2024 |
| 1000 tablet in 1 bottle | 58657-730-10 | Method Pharmaceuticals | 15 June 2024 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 58657-930-01 | Method Pharmaceuticals | 1 June 2025 |
| 5 blister pack in 1 carton / 10 tablet in 1 blister pack | 58657-930-05 | Method Pharmaceuticals | 1 June 2025 |
| 100 tablet in 1 bottle | 72888-009-01 | Advagen Pharma | 1 April 2018 |
| 500 tablet in 1 bottle | 72888-009-05 | Advagen Pharma | 1 April 2018 |
| 90 tablet in 1 bottle | 62135-472-90 | Chartwell RX | 3 March 2023 |
| 100 tablet in 1 bottle | 71930-066-12 | Eywa Pharma | 27 May 2021 |
| 1000 tablet in 1 bottle | 71930-066-13 | Eywa Pharma | 27 May 2021 |
| 500 tablet in 1 bottle | 71930-066-52 | Eywa Pharma | 27 May 2021 |
| 100 tablet in 1 bottle, plastic | 0527-1333-01 | Lannett | 22 September 2021 |
| 100 tablet in 1 bottle | 16571-169-01 | Rising Pharma Holdings | 1 March 2024 |
| 100 tablet in 1 bottle | 52817-319-10 | TruPharma | 1 April 2018 |
| 100 tablet in 1 bottle | 72865-296-01 | XLCare Pharmaceuticals | 5 February 2025 |
| 30 tablet in 1 bottle | 71335-3050-1 | Bryant Ranch Prepack | 5 February 2026 |
| 30 tablet in 1 bottle | 71335-3051-1 | Bryant Ranch Prepack | 5 February 2026 |
| 100 tablet in 1 bottle | 72162-2372-1 | Bryant Ranch Prepack | 18 July 2024 |
| 100 tablet in 1 bottle | 72162-2448-1 | Bryant Ranch Prepack | 22 January 2025 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-804-65 | American Health Packaging | 26 May 2024 |
| 100 tablet in 1 bottle | 76420-356-01 | Asclemed | 22 May 2025 |
| 30 tablet in 1 bottle | 76420-356-30 | Asclemed | 22 May 2025 |
| 60 tablet in 1 bottle | 76420-356-60 | Asclemed | 22 May 2025 |
| 90 tablet in 1 bottle | 76420-356-90 | Asclemed | 22 May 2025 |
| 50 blister pack in 1 box / 1 tablet in 1 blister pack | 50268-105-15 | AvPAK | 11 May 2021 |
| 10 blister pack in 1 bag / 1 tablet in 1 blister pack | 55154-4349-0 | Cardinal Health | 22 November 2024 |
| 100 tablet in 1 bottle | 51407-972-01 | Golden State Medical Supply | 14 March 2025 |
| 50 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-7558-06 | Major Pharmaceuticals | 22 October 2025 |
| 100 tablet in 1 bottle, plastic | 72789-478-01 | PD-Rx Pharmaceuticals | 21 January 2025 |
| 30 tablet in 1 bottle, plastic | 72789-478-30 | PD-Rx Pharmaceuticals | 28 August 2025 |
| 90 tablet in 1 bottle | 82804-219-90 | Proficient Rx | 24 April 2025 |
| 14 tablet in 1 bottle, plastic | 70518-4656-0 | Remedyrepack | 12 May 2026 |
| 15 tablet in 1 blister pack | 0615-8518-05 | Vangard Labs | 14 August 2024 |
| 30 tablet in 1 blister pack | 0615-8518-39 | Vangard Labs | 14 August 2024 |
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
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 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.