Medicine
Pemetrexed disodium hemipentahydrate 500 mg/20 mL powder for injection
Pemetrexed disodium hemipentahydrate 500 mg/20 mL powder for injection is a generic prescription medicine for intravenous use, made by 6 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 °C to 30 °C (59 °F to 86 °F).
Key facts
- Active ingredient (INN)
- Pemetrexed disodium hemipentahydrate
- Brand
- Sold under the generic name
- Strength
- 500 mg/20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial and 12 more
- Manufacturers
- Accord HealthcareIndiaEugiaIndiaCamber PharmaceuticalsIndiaBluePoint LaboratoriesQilu PharmaceuticalSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15 °C to 30 °C (59 °F to 86 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 May 2022
- Identifiers
- RxCUI 1728072, 1728077, 2601728DailyMed set ID dfd19e67-54cb-c062-e053-2995a90a294a, 2ca1ce75-5284-4282-b76a-3700d203c714, 737ead51-f73c-414f-b68f-d3affc27a225 +4NDC 16729-229, 31722-337, 55150-383 +12Application ANDA203485, ANDA215460, ANDA214632 +1
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 4 mL in 1 vial | 16729-229-03 | Accord HealthcareIndia | 25 May 2022 |
| 1 vial in 1 carton / 20 mL in 1 vial | 16729-230-11 | Accord HealthcareIndia | 25 May 2022 |
| 1 vial in 1 carton / 40 mL in 1 vial | 16729-244-38 | Accord HealthcareIndia | 25 May 2022 |
| 1 vial in 1 carton / 4 mL in 1 vial | 55150-381-01 | EugiaIndia | 25 May 2022 |
| 1 vial in 1 carton / 20 mL in 1 vial | 55150-382-01 | EugiaIndia | 25 May 2022 |
| 1 vial in 1 carton / 40 mL in 1 vial | 55150-383-01 | EugiaIndia | 25 May 2022 |
| 1 vial in 1 carton / 4 mL in 1 vial | 31722-336-31 | Camber PharmaceuticalsIndia | 14 June 2024 |
| 1 vial in 1 carton / 20 mL in 1 vial | 31722-337-31 | Camber PharmaceuticalsIndia | 14 June 2024 |
| 1 vial in 1 carton / 4 mL in 1 vial | 67184-0503-1 | Qilu Pharmaceutical | 25 May 2022 |
| 1 vial in 1 carton / 20 mL in 1 vial | 67184-0504-1 | Qilu Pharmaceutical | 25 May 2022 |
| 1 vial in 1 carton / 20 mL in 1 vial | 25021-261-50 | Sagent Pharmaceuticals | 15 December 2024 |
| 1 vial in 1 carton / 4 mL in 1 vial | 68001-535-41 | BluePoint Laboratories | 4 July 2022 |
| 1 vial in 1 carton / 20 mL in 1 vial | 68001-536-41 | BluePoint Laboratories | 4 July 2022 |
| 1 vial in 1 carton / 4 mL in 1 vial | 68001-538-41 | BluePoint Laboratories | 24 June 2022 |
| 1 vial in 1 carton / 20 mL in 1 vial | 68001-539-41 | BluePoint Laboratories | 24 June 2022 |
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 |
| 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
Other strengths and forms of Pemetrexed disodium hemipentahydrate
Clinical summary
Pemetrexed disodium hemipentahydrate 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), among other approved uses. MedsAcross supplies Pemetrexed disodium hemipentahydrate 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 disodium hemipentahydrateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PEMRYDI RTU prescribing information (Amneal Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pemetrexed disodium hemipentahydrate 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.