Quick answers
- What is Cisplatin used for?
- The FDA-approved label (Cisplatin, WG Critical Care, LLC, June 24, 2026) says: “Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer • Advanced ovarian cancer • Advanced bladder cancer 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cisplatin have a boxed warning?
- Yes. The FDA label for Cisplatin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cisplatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cisplatin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 1, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cisplatin?
- 10 companies list prescription products of Cisplatin in the FDA NDC Directory, including WG Critical Care, LLC, BluePoint Laboratories and Hikma Pharmaceuticals USA Inc..
What Cisplatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cisplatin for injection is a platinum-based drug indicated for the treatment of: • Advanced testicular cancer • Advanced ovarian cancer • Advanced bladder cancer 1.1 Advanced Testicular Cancer Cisplatin for injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin for injection is indicated for the treatment of advanced ovarian cancer. …
— FDA label: Cisplatin, WG Critical Care, LLC, effective June 24, 2026. Read the full label on DailyMed →
The FDA has 12 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. Read it on the full label →
12 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 19 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.
- WG Critical Care, LLC4 products
- BluePoint Laboratories3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Gland Pharma Limited2 products
- Teva Parenteral Medicines, Inc.2 products
- Fosun Pharma USA Inc.2 products
- Fresenius Kabi USA, LLC1 product
- Apotex Corp.1 product
- Accord Healthcare Inc.1 product
- Sagent Pharmaceuticals1 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 |
|---|---|---|---|
| NDA018057 CISPLATIN, PLATINOL, PLATINOL-AQ | Hq Spclt Pharma | December 19, 1978 | 66, latest March 24, 2022 2022: Labeling · 2019: Manufacturing (CMC) · 2017: Manufacturing (CMC) |
Generic approvals (6)
- ANDA074735Fresenius Kabi USA · July 16, 1999
- ANDA074656Pharmachemie Bv · May 16, 2000
- ANDA075036Hikma · November 7, 2000
- ANDA206774Accord Hlthcare · August 18, 2015
- ANDA207323Gland · March 17, 2017
- ANDA218868Qilu · May 10, 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.
-
October 1, 2024 · Class II · Terminated · D-0010-2025
Failed Impurities/Degradation Specifications.
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahm — ACCORD HEALTHCARE, INC.
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) | 309311, 1736854 |
|---|---|
| SPL set ID of the quoted label | 508496cb-3441-46b3-a4fe-e0d440e6adc6 |
| FDA labels (SPL) | 12 |
| FDA applications | NDA018057, 6 ANDA |
| Active ingredients (FDA) | CISPLATIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cisplatin, WG Critical Care, LLC, effective June 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 →