Skip to content
MedsAcross

Medicine

Teriflunomide 14 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Teriflunomide 14 mg tablet is a generic prescription medicine for oral use, made by 14 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 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Teriflunomide
Brand
Sold under the generic name
Strength
14 mg
Dosage form
Tablet
Route
Oral
Packs
2 blister pack, 30 tablets, 1000 tablets and 27 more
Manufacturers
Alembic PharmaceuticalsIndiaZydus LifesciencesIndiaGlenmark PharmaceuticalsIndiaMSN LaboratoriesIndiaNatco PharmaIndiaAurobindo PharmaIndiaBioconIndiaAccord HealthcareIndiaCamber PharmaceuticalsIndiaConcord BiotechIndia
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
L04AK02 Teriflunomide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
24 April 2019
Identifiers
RxCUI 1310525, 1310533DailyMed set ID c424959d-00c9-4e76-aba6-cc7464d8e903, 2b084b44-f15b-4b16-b700-4382434f2136, 2fd80242-c607-4c50-b497-8259abb4a2f8 +13NDC 0480-3156, 46708-314, 59651-055 +14Application ANDA209700, ANDA209572, ANDA209638 +9

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.

PackCodeLabelerMarketed since
2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack46708-314-14Alembic PharmaceuticalsIndia25 January 2023
30 tablet, film coated in 1 bottle46708-314-30Alembic PharmaceuticalsIndia25 January 2023
1000 tablet, film coated in 1 bottle46708-314-91Alembic PharmaceuticalsIndia25 January 2023
2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack62332-314-14Alembic PharmaceuticalsIndia25 January 2023
30 tablet, film coated in 1 bottle62332-314-30Alembic PharmaceuticalsIndia25 January 2023
1000 tablet, film coated in 1 bottle62332-314-91Alembic PharmaceuticalsIndia25 January 2023
2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack69539-033-41MSN LaboratoriesIndia24 April 2019
30 tablet, film coated in 1 bottle69539-316-30MSN LaboratoriesIndia4 February 2023
2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack69539-316-41MSN LaboratoriesIndia24 April 2019
30 tablet, film coated in 1 bottle70710-1115-3Zydus LifesciencesIndia14 February 2023
2 carton in 1 carton / 1 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack70710-1115-8Zydus LifesciencesIndia14 February 2023
30 tablet, film coated in 1 bottle70771-1011-3Zydus LifesciencesIndia14 February 2023
2 carton in 1 carton / 1 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack70771-1011-8Zydus LifesciencesIndia14 February 2023
30 tablet, film coated in 1 bottle16729-400-10Accord HealthcareIndia13 March 2023
2 blister pack in 1 carton / 14 tablet in 1 blister pack59651-055-28Aurobindo PharmaIndia28 February 2023
30 tablet in 1 bottle59651-055-30Aurobindo PharmaIndia28 February 2023
30 tablet, film coated in 1 bottle70377-018-11BioconIndia13 March 2023
2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack70377-018-91BioconIndia13 March 2023
30 tablet, film coated in 1 bottle31722-247-30Camber PharmaceuticalsIndia13 March 2023
30 tablet, film coated in 1 bottle68254-5010-1Concord BiotechIndia7 July 2025
2 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack68462-424-15Glenmark PharmaceuticalsIndia19 January 2023
30 tablet, film coated in 1 bottle68462-424-30Glenmark PharmaceuticalsIndia19 January 2023
1 blister pack in 1 carton / 5 tablet, film coated in 1 blister pack68462-424-85Glenmark PharmaceuticalsIndia19 January 2023
30 tablet in 1 bottle69339-170-03Natco PharmaIndia2 January 2024
90 tablet in 1 bottle69339-170-09Natco PharmaIndia2 January 2024
2 blister pack in 1 carton / 30 tablet in 1 blister pack69339-170-93Natco PharmaIndia17 June 2023
30 tablet, film coated in 1 bottle82249-112-30Civica Script26 October 2026
30 tablet, film coated in 1 bottle, plastic0378-0628-93Mylan Pharmaceuticals31 March 2023
30 tablet, film coated in 1 bottle0480-3156-56Teva Pharmaceuticals13 March 2023
30 tablet, film coated in 1 bottle42291-831-30AvKARE20 April 2023

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 12 September 2012Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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

Alternatives

Other makers and brands of Teriflunomide 14 mg tablet.

Compare 1

Other strengths and forms of Teriflunomide

Clinical summary

Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Teriflunomide 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 Teriflunomide

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

Data sources

Need Teriflunomide 14 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.