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MedsAcross

Medicine

Tizanidine 2 mg tablet

Tizanidine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Tizanidine 2 mg tablet is a generic prescription medicine for oral use, made by 30 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

Available on request

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 15° to 30°C (59° to 86°F).

Key facts

Active ingredient (INN)
Tizanidine
Brand
Sold under the generic name
Strength
2 mg
Dosage form
Tablet
Route
Oral
Packs
500 tablets, 150 tablets, 1000 tablets and 155 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaUnichem LaboratoriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackApotexRising Pharma Holdings30 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted 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
3 July 2002
Identifiers
RxCUI 313412, 313413DailyMed set ID e13292b0-9858-4405-8787-a2392d1b6d75, afc90292-c6bf-2d96-e053-2995a90abf00, 3670f9e3-988d-48e6-9df0-d403d699e08a +37NDC 71335-1799, 80425-0425, 68084-775 +37Application ANDA076416, ANDA076286, ANDA076282 +5

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 30 labelers. The register lists 158 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
500 tablet in 1 bottle67877-613-05Ascend LaboratoriesIndia27 January 2019
150 tablet in 1 bottle67877-613-15Ascend LaboratoriesIndia27 January 2019
150 tablet in 1 bottle84386-023-77Aurobindo PharmaIndia1 September 2026
1000 tablet in 1 bottle84386-023-99Aurobindo PharmaIndia1 September 2026
300 tablet in 1 bottle55111-179-03Dr. Reddy's LaboratoriesIndia3 July 2002
1000 tablet in 1 bottle55111-179-10Dr. Reddy's LaboratoriesIndia3 July 2002
150 tablet in 1 bottle55111-179-15Dr. Reddy's LaboratoriesIndia3 July 2002
30 tablet in 1 bottle55111-179-30Dr. Reddy's LaboratoriesIndia3 July 2002
1000 tablet in 1 bottle57664-502-18Sun Pharmaceutical IndustriesIndia11 December 2003
150 tablet in 1 bottle57664-502-89Sun Pharmaceutical IndustriesIndia11 December 2003
500 tablet in 1 bottle, plastic29300-168-05Unichem LaboratoriesIndia1 April 2013
1000 tablet in 1 bottle, plastic29300-168-10Unichem LaboratoriesIndia1 April 2013
150 tablet in 1 bottle, plastic29300-168-15Unichem LaboratoriesIndia1 April 2013
90 tablet in 1 bottle, plastic29300-168-19Unichem LaboratoriesIndia6 January 2023
30 tablet in 1 bottle72578-096-06Viona PharmaceuticalsIndia4 March 2021
1000 tablet in 1 bottle72578-096-10Viona PharmaceuticalsIndia4 March 2021
150 tablet in 1 bottle72578-096-21Viona PharmaceuticalsIndia4 March 2021
10 blister pack in 1 carton / 10 tablet in 1 blister pack72578-096-77Viona PharmaceuticalsIndia4 March 2021
1000 tablet in 1 bottle70771-1335-0Zydus LifesciencesIndia13 September 2018
30 tablet in 1 bottle70771-1335-3Zydus LifesciencesIndia13 September 2018
10 blister pack in 1 carton / 10 tablet in 1 blister pack70771-1335-4Zydus LifesciencesIndia13 September 2018
150 tablet in 1 bottle70771-1335-8Zydus LifesciencesIndia13 September 2018
100 tablet in 1 bottle60505-0251-1Apotex16 January 2004
1000 tablet in 1 bottle60505-0251-2Apotex16 January 2004
150 tablet in 1 bottle60505-0251-3Apotex16 January 2004
60 tablet in 1 bottle82461-720-60Medcore10 April 2026
30 tablet in 1 bottle64980-658-03Rising Pharma Holdings15 December 2024
1000 tablet in 1 bottle64980-658-10Rising Pharma Holdings15 December 2024
150 tablet in 1 bottle64980-658-15Rising Pharma Holdings15 December 2024
1000 tablet in 1 bottle63629-2370-1Bryant Ranch Prepack18 February 2021
40 tablet in 1 bottle63629-3209-0Bryant Ranch Prepack8 December 2021
30 tablet in 1 bottle63629-3209-1Bryant Ranch Prepack24 August 2007
60 tablet in 1 bottle63629-3209-2Bryant Ranch Prepack25 April 2007
90 tablet in 1 bottle63629-3209-3Bryant Ranch Prepack6 March 2007
120 tablet in 1 bottle63629-3209-4Bryant Ranch Prepack17 September 2008
100 tablet in 1 bottle63629-3209-5Bryant Ranch Prepack13 October 2008
84 tablet in 1 bottle63629-3209-6Bryant Ranch Prepack4 March 2010
28 tablet in 1 bottle63629-3209-7Bryant Ranch Prepack4 March 2010
21 tablet in 1 bottle63629-3209-8Bryant Ranch Prepack17 November 2010
160 tablet in 1 bottle63629-3209-9Bryant Ranch Prepack1 August 2011

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 27 November 1996Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 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 Tizanidine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Tizanidine 2 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.