Quick answers
- What is Pemetrexed used for?
- The FDA-approved label (Alimta, Eli Lilly and Company, May 19, 2023) says: “ALIMTA ® 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. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pemetrexed have a boxed warning?
- No. None of the 30 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pemetrexed?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pemetrexed been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 29, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Pemetrexed?
- 23 companies list prescription products of Pemetrexed in the FDA NDC Directory, including BluePoint Laboratories, Meitheal Pharmaceuticals Inc. and Hospira, Inc..
What Pemetrexed is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ALIMTA ® 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. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. …
— FDA label: Alimta, Eli Lilly and Company, effective May 19, 2023. Read the full label on DailyMed →
The FDA has 30 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 30 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection · Injection, solution, concentrate · Injection, solution · Solution, concentrate · Injection, powder, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 69 in the FDA NDC Directory |
| Brand names | Pemrydi Rtu, Alimta, Pemfexy, Axtle |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- BluePoint Laboratories8 products
- Meitheal Pharmaceuticals Inc.8 products
- Hospira, Inc.6 products
- Fresenius Kabi USA, LLC4 products
- Avyxa Pharma, LLC4 products
- Accord Healthcare Inc.3 products
- Shilpa Medicare Limited3 products
- Amneal Pharmaceuticals LLC3 products
- Eugia US LLC3 products
- Sandoz Inc3 products
- Dr.Reddys Laboratories Inc3 products
- Zydus Lifesciences Limited3 products
- Teva Pharmaceuticals, Inc.3 products
- NorthStar RxLLC2 products
- Sagent Pharmaceuticals2 products
- Camber Pharmaceuticals, Inc.2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- Waverley Pharma Inc2 products
- Eli Lilly and Company2 products
- Somerset Therapeutics, LLC2 products
- Solco Healthcare US, LLC1 product
- Eagle Pharmaceuticals, Inc.1 product
- Acacia Pharma, Ltd.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021462 ALIMTA | Lilly | February 4, 2004 | 25, latest August 31, 2022 2022: Efficacy · 2019: Efficacy · 2018: Efficacy |
| NDA208419 PEMETREXED | Actavis | August 21, 2020 | 3, latest November 22, 2022 2022: Efficacy · 2022: Efficacy · 2022: Efficacy |
| NDA209472 PEMFEXY | Eagle Pharms | February 8, 2020 | 2, latest December 14, 2022 2022: Efficacy · 2020: Manufacturing (CMC) |
| NDA210661 AXTLE | Avyxa Holdings | June 28, 2024 | 3, latest October 3, 2025 2025: Efficacy · 2025: Labeling · 2024: Labeling |
| NDA214218 PEMETREXED DISODIUM | Hospira | June 22, 2022 | — |
| NDA214657 PEMETREXED DISODIUM | Sandoz | May 26, 2022 | 2, latest December 15, 2025 2025: Labeling · 2023: Labeling |
| NDA215179 PEMETREXED | Shilpa | May 22, 2023 | 1, latest November 15, 2024 2024: Labeling |
Generic approvals (14)
- ANDA090384Fresenius Kabi USA · May 25, 2022
- ANDA202596DR Reddys · May 25, 2022
- ANDA203485Accord Hlthcare · May 25, 2022
- ANDA203774Apotex · May 25, 2022
- ANDA204890Qilu Pharm Hainan · May 25, 2022
- ANDA208696Jiangsu Hansoh Pharm · May 25, 2022
- ANDA209085Apotex · May 25, 2022
- ANDA209851Apotex · May 25, 2022
- ANDA211899Somerset Theraps LLC · May 25, 2022
- ANDA214073Zydus Pharms · May 25, 2022
- ANDA214632Eugia Pharma · May 25, 2022
- ANDA215479Meitheal · December 13, 2022
- ANDA216582Prinston Inc · December 11, 2023
- ANDA215460Hetero Labs Ltd Vi · June 14, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 29, 2026 · Class II · Ongoing · D-0764-2026
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC — Shilpa Medicare Limited
-
July 29, 2026 · Class II · Ongoing · D-0765-2026
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: — Shilpa Medicare Limited
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1728072, 1728075, 1728077, 1728079, 2590672, 2590677, 2601728, 2602136, 2602363, 2602365 … (+9) |
|---|---|
| SPL set ID of the quoted label | f5a860f3-37ec-429c-ae04-9c88d7c55c08 |
| FDA labels (SPL) | 30 |
| FDA applications | NDA021462, NDA208419, NDA209472, NDA210661, NDA214218, NDA214657, NDA215179, 14 ANDA |
| Active ingredients (FDA) | PEMETREXED |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Alimta, Eli Lilly and Company, effective May 19, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →