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Medicine

Pemetrexed 500 mg/20 mL powder for injection

Pemetrexed · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Pemetrexed 500 mg/20 mL powder for injection is a generic prescription medicine for intravenous use, made by 7 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 powder at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to…

Key facts

Active ingredient (INN)
Pemetrexed
Brand
Sold under the generic name
Strength
500 mg/20 mL
Dosage form
Powder for injection
Route
Intravenous
Packs
1 vial and 17 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaBluePoint LaboratoriesFresenius KabiMeitheal PharmaceuticalsAvyxa PharmaSomerset TherapeuticsWaverley Pharma
Origin register
US FDA, United States
Storage
Store powder at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store reconstituted and infusion solutions at refrigerated, 2°C to 8°C (36°F to 46°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01BA04 Pemetrexed
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
4 June 2018
Identifiers
RxCUI 2602136, 1728072, 1728077 +1DailyMed set ID 14974d4e-2f01-4e02-aea2-c28b3ca0781c, 4cc1574b-3d2f-489b-9ad3-55695bb97200, 39219e4b-80a6-4d4f-96a3-1202e542d050 +6NDC 68001-545, 68001-543, 70069-835 +17Application ANDA209851, ANDA203774, ANDA211899 +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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
1 vial, single-dose in 1 carton / 40 mL in 1 vial, single-dose43598-370-74Dr. Reddy's LaboratoriesIndia25 May 2022
1 vial, single-dose in 1 carton / 4 mL in 1 vial, single-dose43598-386-62Dr. Reddy's LaboratoriesIndia25 May 2022
1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose43598-387-11Dr. Reddy's LaboratoriesIndia25 May 2022
1 vial, single-use in 1 carton / 4 mL in 1 vial, single-use63323-134-10Fresenius Kabi25 May 2022
1 vial, single-use in 1 carton / 20 mL in 1 vial, single-use63323-450-50Fresenius Kabi25 May 2022
1 vial, single-use in 1 carton / 30 mL in 1 vial, single-use63323-621-00Fresenius Kabi25 May 2022
1 vial, single-use in 1 carton / 40 mL in 1 vial, single-use63323-622-00Fresenius Kabi25 May 2022
1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose71288-146-50Meitheal Pharmaceuticals13 December 2022
1 vial, single-dose in 1 carton / 30 mL in 1 vial, single-dose71288-147-50Meitheal Pharmaceuticals13 December 2022
1 vial, single-dose in 1 carton / 40 mL in 1 vial, single-dose71288-148-51Meitheal Pharmaceuticals13 December 2022
1 vial in 1 carton / 4 mL in 1 vial83831-111-01Avyxa Pharma1 January 2025
1 vial in 1 carton / 20 mL in 1 vial83831-112-01Avyxa Pharma1 January 2025
1 vial in 1 carton / 4 mL in 1 vial70069-834-01Somerset Therapeutics15 April 2025
1 vial in 1 carton / 20 mL in 1 vial70069-835-01Somerset Therapeutics15 April 2025
1 vial in 1 carton / 4 mL in 1 vial72338-100-01Waverley Pharma4 June 2018
1 vial in 1 carton / 20 mL in 1 vial72338-101-01Waverley Pharma4 June 2018
1 vial in 1 carton / 4 mL in 1 vial68001-543-41BluePoint Laboratories1 September 2022
1 vial in 1 carton / 20 mL in 1 vial68001-544-41BluePoint Laboratories1 September 2022
1 vial in 1 carton / 30 mL in 1 vial68001-545-41BluePoint Laboratories1 September 2023
1 vial in 1 carton / 40 mL in 1 vial68001-546-41BluePoint Laboratories1 September 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 4 February 2004Drugs@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 Pemetrexed

Clinical summary

Pemetrexed is a folate analog metabolic inhibitor indicated in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. MedsAcross supplies Pemetrexed 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 Pemetrexed

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

Data sources

Need Pemetrexed 500 mg/20 mL powder for injection 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.