Quick answers
- What is Oxaliplatin used for?
- The FDA-approved label (Oxaliplatin, Gland Pharma Limited, August 24, 2026) says: “Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxaliplatin have a boxed warning?
- Yes. The FDA label for Oxaliplatin has a boxed warning (“WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Oxaliplatin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 29, 2026). Ask your pharmacist about alternatives.
- Has Oxaliplatin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oxaliplatin?
- 16 companies list prescription products of Oxaliplatin in the FDA NDC Directory, including Meitheal Pharmaceuticals Inc., Qilu Pharmaceutical Co., Ltd. and Gland Pharma Limited.
What Oxaliplatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for …
— FDA label: Oxaliplatin, Gland Pharma Limited, effective August 24, 2026. Read the full label on DailyMed →
The FDA has 24 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.
This label has a boxed warning. Its heading: WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS
. Read it on the full label →
24 of 24 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, powder, lyophilized, for solution · Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 40 in the FDA NDC Directory |
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.
- Meitheal Pharmaceuticals Inc.6 products
- Qilu Pharmaceutical Co., Ltd.5 products
- Gland Pharma Limited5 products
- Sandoz Inc4 products
- NorthStar Rx LLC4 products
- Eugia US LLC2 products
- Shandong New Time Pharmaceutical Co., Ltd.2 products
- Baxter Healthcare Corporation2 products
- Apotex Corp.2 products
- Mylan Institutional LLC2 products
- Fosun Pharma USA Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- BluePoint Laboratories1 product
- Accord Healthcare Inc.1 product
- Sagent Pharmaceuticals1 product
- Hospira, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (13)
- ANDA078813Hospira Worldwide · August 7, 2009
- ANDA078817Sandoz · January 24, 2011
- ANDA091358Mylan Labs Ltd · August 7, 2012
- ANDA203869Hengrui Pharma · June 18, 2014
- ANDA204616Qilu Pharm Hainan · May 11, 2016
- ANDA204368Qilu Pharm Hainan · June 7, 2016
- ANDA207325Gland · February 10, 2017
- ANDA207474Accord Hlthcare · March 21, 2017
- ANDA207385Gland · May 23, 2017
- ANDA205529Eugia Pharma · September 6, 2017
- ANDA217348Meitheal · January 11, 2024
- ANDA217925Hetero Labs Ltd Vi · January 27, 2025
- ANDA219765Shandong · January 15, 2026
Shortage status
To be discontinued · updated June 29, 2026 · first posted June 29, 2026
| Product | Oxaliplatin, Injection, 5 mg/1 mL (NDC 25021-233-20) |
|---|---|
| Company | Jiangsu Hengrui Pharmaceuticals Co., Ltd. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Oxaliplatin, Gland Pharma Limited, effective August 24, 2026; 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 →