Quick answers
- What is Cytarabine used for?
- The FDA-approved label (Cytarabine, Meitheal Pharmaceuticals Inc., April 8, 2024) says: “Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cytarabine have a boxed warning?
- Yes. The FDA label for Cytarabine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cytarabine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cytarabine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 27, 2012 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cytarabine?
- 5 companies list prescription products of Cytarabine in the FDA NDC Directory, including Hospira, Inc., Meitheal Pharmaceuticals Inc. and Gland Pharma Limited.
What Cytarabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. …
— FDA label: Cytarabine, Meitheal Pharmaceuticals Inc., effective April 8, 2024. Read the full label on DailyMed →
The FDA has 8 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 →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous · Subcutaneous · Intrathecal |
| Prescription products | 14 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.
- Hospira, Inc.5 products
- Meitheal Pharmaceuticals Inc.4 products
- Gland Pharma Limited2 products
- Sagent Pharmaceuticals2 products
- Fresenius Kabi USA, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (11)
- ANDA071868Hospira · June 4, 1990
- ANDA072168Hospira · August 31, 1990
- ANDA072945Hospira · February 28, 1994
- ANDA075383Hospira · November 22, 1999
- ANDA076512Fresenius Kabi USA · January 15, 2004
- ANDA206190Meitheal · November 9, 2017
- ANDA205696Meitheal · July 17, 2018
- ANDA211937Gland · December 23, 2019
- ANDA211938Gland · December 23, 2019
- ANDA206189Meitheal · June 26, 2020
- ANDA208485Meitheal · February 28, 2022
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.
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June 27, 2012 · Class II · Terminated · D-1680-2012
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the parti
Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46 — Hospira 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) | 240416, 249364, 1731355 |
|---|---|
| SPL set ID of the quoted label | 8105e590-fc7e-45b7-9604-c2d0d1be5eac |
| FDA labels (SPL) | 8 |
| FDA applications | 11 ANDA |
| Active ingredients (FDA) | CYTARABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cytarabine, Meitheal Pharmaceuticals Inc., effective April 8, 2024; 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 →