Medicine
Tizanidine 4 mg capsule
Tizanidine 4 mg capsule is a generic prescription medicine for oral use, made by 18 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 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F).
Key facts
- Active ingredient (INN)
- Tizanidine
- Brand
- Sold under the generic name
- Strength
- 4 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 80 blister pack, 30 capsules, 150 capsules and 72 more
- Manufacturers
- Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCadila PharmaceuticalsIndiaBryant Ranch PrepackPreferred PharmaceuticalsApotexAdvagen PharmaActavis Pharma18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), 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
- M03BX02 Tizanidine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 February 2012
- Identifiers
- RxCUI 485485, 485484, 485486DailyMed set ID 04febb37-00d6-4279-8c5f-171950278c8f, 07b8db58-d037-477e-a62f-025e8a5afcb4, 7f39499a-98cf-4d13-9b07-ccb5c22e43c8 +23NDC 72162-1861, 76420-901, 72888-002 +23Application ANDA212196, ANDA213798, ANDA213544 +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
A sample of 40 packs from 18 labelers. The register lists 75 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 80 blister pack in 1 carton / 8 capsule in 1 blister pack | 46708-492-08 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 30 capsule in 1 bottle | 46708-492-30 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 150 capsule in 1 bottle | 46708-492-41 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 1000 capsule in 1 bottle | 46708-492-91 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 80 blister pack in 1 carton / 8 capsule in 1 blister pack | 62332-492-08 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 30 capsule in 1 bottle | 62332-492-30 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 150 capsule in 1 bottle | 62332-492-41 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 1000 capsule in 1 bottle | 62332-492-91 | Alembic PharmaceuticalsIndia | 15 January 2020 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 70710-1112-4 | Zydus LifesciencesIndia | 27 April 2017 |
| 500 capsule in 1 bottle | 70710-1112-5 | Zydus LifesciencesIndia | 27 April 2017 |
| 150 capsule in 1 bottle | 70710-1112-8 | Zydus LifesciencesIndia | 27 April 2017 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 70771-1068-4 | Zydus LifesciencesIndia | 27 April 2017 |
| 500 capsule in 1 bottle | 70771-1068-5 | Zydus LifesciencesIndia | 27 April 2017 |
| 150 capsule in 1 bottle | 70771-1068-8 | Zydus LifesciencesIndia | 27 April 2017 |
| 500 capsule in 1 bottle | 67877-611-05 | Ascend LaboratoriesIndia | 29 March 2019 |
| 150 capsule in 1 bottle | 67877-611-15 | Ascend LaboratoriesIndia | 29 March 2019 |
| 1 blister pack in 1 carton / 10 capsule in 1 blister pack | 67877-611-33 | Ascend LaboratoriesIndia | 29 March 2019 |
| 150 capsule in 1 bottle | 59651-315-77 | Aurobindo PharmaIndia | 24 March 2020 |
| 150 capsule in 1 bottle | 71209-065-07 | Cadila PharmaceuticalsIndia | 29 December 2017 |
| 150 capsule, gelatin coated in 1 bottle, plastic | 0591-2789-86 | Actavis Pharma | 6 February 2012 |
| 30 capsule in 1 bottle | 72888-002-01 | Advagen Pharma | 30 June 2026 |
| 150 capsule in 1 bottle | 72888-002-15 | Advagen Pharma | 27 May 2020 |
| 30 capsule, gelatin coated in 1 bottle | 60505-2649-3 | Apotex | 6 February 2012 |
| 150 capsule, gelatin coated in 1 bottle | 60505-2649-7 | Apotex | 6 February 2012 |
| 1000 capsule, gelatin coated in 1 bottle | 60505-2649-8 | Apotex | 6 February 2012 |
| 150 capsule in 1 bottle, plastic | 50742-225-15 | Ingenus Pharmaceuticals | 20 March 2019 |
| 150 capsule in 1 bottle | 85742-032-30 | Kanchan Healthcare | 29 December 2017 |
| 150 capsule in 1 bottle | 72241-042-07 | Modavar Pharmaceuticals | 29 December 2017 |
| 150 capsule in 1 bottle | 63629-8872-1 | Bryant Ranch Prepack | 29 March 2019 |
| 150 capsule in 1 bottle | 71335-2209-1 | Bryant Ranch Prepack | 4 August 2023 |
| 1 capsule in 1 bottle | 71335-2559-1 | Bryant Ranch Prepack | 24 January 2025 |
| 30 capsule in 1 bottle | 71335-2559-2 | Bryant Ranch Prepack | 24 January 2025 |
| 60 capsule in 1 bottle | 71335-2559-3 | Bryant Ranch Prepack | 24 January 2025 |
| 90 capsule in 1 bottle | 71335-2559-4 | Bryant Ranch Prepack | 24 January 2025 |
| 150 capsule in 1 bottle | 72162-1861-2 | Bryant Ranch Prepack | 29 March 2019 |
| 100 capsule in 1 bottle, plastic | 68788-8747-1 | Preferred Pharmaceuticals | 26 September 2024 |
| 20 capsule in 1 bottle, plastic | 68788-8747-2 | Preferred Pharmaceuticals | 26 September 2024 |
| 30 capsule in 1 bottle, plastic | 68788-8747-3 | Preferred Pharmaceuticals | 26 September 2024 |
| 60 capsule in 1 bottle, plastic | 68788-8747-6 | Preferred Pharmaceuticals | 26 September 2024 |
| 120 capsule in 1 bottle, plastic | 68788-8747-8 | Preferred Pharmaceuticals | 26 September 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 27 November 1996 | 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 Tizanidine 4 mg capsule.
Other strengths and forms of Tizanidine
Clinical summary
Tizanidine is a central alpha-2 adrenergic agonist indicated for the treatment of spasticity in adults. It is available as tablets, capsules and oral solution. MedsAcross supplies Tizanidine 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 TizanidineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zanaflex prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
Need Tizanidine 4 mg capsule 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.