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Medicine

Methotrexate 2.5 mg tablet

Methotrexate · Oral
Available on requestPrescription onlyUS FDAGeneric name

Methotrexate 2.5 mg tablet is a generic prescription medicine for oral use, made by 22 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°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59°…

Key facts

Active ingredient (INN)
Methotrexate
Brand
Sold under the generic name
Strength
2.5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 36 tablets, 500 tablets and 72 more
Manufacturers
Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaBryant Ranch PrepackTeva PharmaceuticalsChartwell RXElite LaboratoriesHikma Pharmaceuticals22 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 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
L01BA01 Methotrexate
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 November 1990
Identifiers
RxCUI 105585DailyMed set ID 4a04756f-e1c9-4d1e-b309-7be31c9176d6, 9b34b1d8-d125-41a2-9f6f-3fab67b573bd, 874c7f43-a3be-4236-89cc-24c44e3c5813 +27NDC 72162-2647, 0555-0572, 16729-486 +27Application ANDA217552, ANDA081099, ANDA213343 +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 22 labelers. The register lists 75 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle46708-730-31Alembic PharmaceuticalsIndia4 June 2024
36 tablet in 1 bottle46708-730-36Alembic PharmaceuticalsIndia4 June 2024
100 tablet in 1 bottle62332-730-31Alembic PharmaceuticalsIndia4 June 2024
36 tablet in 1 bottle62332-730-36Alembic PharmaceuticalsIndia4 June 2024
100 tablet in 1 bottle68382-775-01Zydus LifesciencesIndia9 February 2017
500 tablet in 1 bottle68382-775-05Zydus LifesciencesIndia9 February 2017
1000 tablet in 1 bottle68382-775-10Zydus LifesciencesIndia9 February 2017
90 tablet in 1 bottle68382-775-16Zydus LifesciencesIndia9 February 2017
36 tablet in 1 bottle68382-775-60Zydus LifesciencesIndia9 February 2017
100 blister pack in 1 carton / 1 tablet in 1 blister pack68382-775-77Zydus LifesciencesIndia9 February 2017
1000 tablet in 1 bottle70771-1058-0Zydus LifesciencesIndia9 February 2017
100 tablet in 1 bottle70771-1058-1Zydus LifesciencesIndia9 February 2017
36 tablet in 1 bottle70771-1058-3Zydus LifesciencesIndia9 February 2017
500 tablet in 1 bottle70771-1058-5Zydus LifesciencesIndia9 February 2017
100 blister pack in 1 carton / 1 tablet in 1 blister pack70771-1058-7Zydus LifesciencesIndia9 February 2017
90 tablet in 1 bottle70771-1058-9Zydus LifesciencesIndia9 February 2017
100 tablet in 1 bottle16729-486-01Accord HealthcareIndia24 August 2020
100 tablet in 1 bottle59651-182-01Aurobindo PharmaIndia30 January 2020
36 tablet in 1 bottle59651-182-36Aurobindo PharmaIndia30 January 2020
100 tablet in 1 bottle47335-235-83Sun Pharmaceutical IndustriesIndia10 November 2017
36 tablet in 1 bottle47335-235-96Sun Pharmaceutical IndustriesIndia10 November 2017
36 tablet in 1 bottle62135-772-35Chartwell RX29 August 2023
100 tablet in 1 bottle, plastic64850-330-01Elite Laboratories16 May 2024
100 tablet in 1 bottle, plastic0054-4550-25Hikma Pharmaceuticals1 August 1994
20 blister pack in 1 carton / 1 tablet in 1 blister pack51079-670-05Mylan Institutional13 July 1995
100 tablet in 1 bottle, plastic0378-0014-01Mylan Pharmaceuticals18 May 1992
100 tablet in 1 bottle0555-0572-02Teva Pharmaceuticals1 November 1990
36 tablet in 1 bottle0555-0572-35Teva Pharmaceuticals1 November 1990
30 tablet in 1 bottle71335-0782-1Bryant Ranch Prepack25 February 2019
12 tablet in 1 bottle71335-0782-2Bryant Ranch Prepack9 April 2021
20 tablet in 1 bottle71335-0782-3Bryant Ranch Prepack9 April 2021
100 tablet in 1 bottle71335-0782-4Bryant Ranch Prepack19 April 2018
36 tablet in 1 bottle71335-0782-5Bryant Ranch Prepack9 April 2021
24 tablet in 1 bottle71335-0782-6Bryant Ranch Prepack9 April 2021
90 tablet in 1 bottle71335-0782-7Bryant Ranch Prepack9 April 2021
4 tablet in 1 bottle71335-0782-8Bryant Ranch Prepack9 April 2021
30 tablet in 1 bottle71335-1118-1Bryant Ranch Prepack25 February 2019
12 tablet in 1 bottle71335-1118-2Bryant Ranch Prepack17 May 2024
20 tablet in 1 bottle71335-1118-3Bryant Ranch Prepack17 May 2024
100 tablet in 1 bottle71335-1118-4Bryant Ranch Prepack17 May 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 7 December 1953Drugs@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

Other strengths and forms of Methotrexate

Clinical summary

Methotrexate is a folate analog metabolic inhibitor indicated for neoplastic diseases for the, among other approved uses. It is available as injection, tablets and powder for injection for oral, subcutaneous and intramuscular use. MedsAcross supplies Methotrexate 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 Methotrexate

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

Data sources

Need Methotrexate 2.5 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.