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Prescription medicine · generic available

Ondansetron

Also listed by the FDA as: ondansetron hydrochloride · ondansetron

Drug class: Serotonin-3 Receptor Antagonist

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
7Recalls (FDA reports)
70Companies
2006First FDA approval on file

Quick answers

What is Ondansetron used for?
The FDA-approved label (Ondansetron, Remedyrepack Inc., September 1, 2026) says: “Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ondansetron have a boxed warning?
No. None of the 214 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Ondansetron?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ondansetron been recalled?
FDA enforcement reports list 7 recalls of products of this medicine; the newest started December 30, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Ondansetron?
70 companies list prescription products of Ondansetron in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Bryant Ranch Prepack and Proficient Rx LP.

What Ondansetron is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron …

— FDA label: Ondansetron, Remedyrepack Inc., effective September 1, 2026. Read the full label on DailyMed →

The FDA has 214 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.

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 214 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet, orally disintegrating · Injection · Solution · Injection, solution · Tablet
RouteOral · Intramuscular · Intravenous
Prescription products275 in the FDA NDC Directory

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ondansetron, by strength and form
Strength and formGeneric or brandPharmacies pay
ondansetron 4 mg
tablet, orally disintegrating		 Generic $0.1230 per tablet
ondansetron 8 mg
tablet, orally disintegrating		 Generic $0.1797 per tablet
ondansetron hydrochloride 2 mg/mL
injection		 Generic $0.1772–$0.1930 per mL
15 packages, lowest to highest
ondansetron hydrochloride 2 mg/mL
injection, solution		 Generic $0.1772–$0.1930 per mL
5 packages, lowest to highest
ondansetron hydrochloride 2 mg/mL
solution		 Generic $0.1772 per mL
ondansetron hydrochloride 4 mg
tablet		 Generic $0.0579 per tablet
ondansetron hydrochloride 4 mg
tablet, film coated		 Generic $0.0579 per tablet
ondansetron hydrochloride 4 mg/5 mL
solution		 Generic $0.2878 per mL
ondansetron hydrochloride 8 mg
tablet		 Generic $0.0767 per tablet
ondansetron hydrochloride 8 mg
tablet, film coated		 Generic $0.0767 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

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.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (35)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. December 30, 2025 · Class II · Ongoing · D-0246-2026

    Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

    Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157 — Glenmark Pharmaceuticals Inc., USA

  2. November 14, 2023 · Class II · Completed · D-0146-2024

    Failed pH Specifications

    Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 3822 — Baxter Healthcare Corporation

  3. April 13, 2022 · Class II · Terminated · D-1103-2022

    cGMP deviations: Temperature abuse

    Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30 — Mckesson Medical-Surgical Inc. Corporate Office

  4. May 22, 2019 · Class III · Terminated · D-1386-2019

    Failed Impurities/Degradation Specifications.

    Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20 — Fresenius Kabi USA, LLC

  5. September 24, 2013 · Class II · Terminated · D-013-2014

    Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.

    Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx Only, Sterile, Hospira Inc., Lake Forest IL 60045, USA, NDC 0409-4755-03 — Hospira Inc.

  6. May 20, 2013 · Class II · Terminated · D-851-2013

    Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot

    Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045. — Hospira, Inc.

  7. September 27, 2012 · Class II · Terminated · D-0296-2015

    Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

    ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02 — Fresenius Kabi USA, LLC

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)104894, 198052, 283504, 312084, 312085, 312086, 312087, 692695, 1314133, 1740467 … (+2)
SPL set ID of the quoted label416be720-82e8-4a6d-8531-c1a29869daae
FDA labels (SPL)214
FDA applications35 ANDA
Active ingredients (FDA)ONDANSETRON

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Ondansetron, Remedyrepack Inc., effective September 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

Report an error → · Information for medicine makers