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ONDANSETRON 2 mg/mL Injection, 2 mL — NDC 51662-1366-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ONDANSETRON 2 mg/mL Injection, 2 mL — NDC 51662-1366-1 (Billing 51662-1366-01)

by HF Acquisition Co LLC, DBA HealthFirst · 2 mL in 1 VIAL

This is a package of 2 mL of ONDANSETRON 2 mg/mL Injection from HF Acquisition Co LLC, DBA HealthFirst, marketed since Dec 2019 and currently FDA-listed. It is this product's only package size.

NDC 51662-1366-01
🏷️ FDA NDC (as labeled) 51662-1366-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Ondansetron (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 30, 2025 — 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. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0246-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1366-1
Product NDC 51662-1366
11-digit billing NDC 51662136601
RxCUI 1740467
UNII NMH84OZK2B
Application # ANDA076972
SPL Set ID 993cd1d7-70a1-a431-e053-2a95a90a5771
Established class (EPC) Serotonin-3 Receptor Antagonist
Mechanism of action Serotonin 3 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-08
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance ONDANSETRON HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1740467
Why two NDCs? The FDA registers this code as 51662-1366-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51662-1366-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Serotonin-3 Receptor Antagonist class.

Pharmacologic class Serotonin-3 Receptor Antagonist
Drug family (ATC) Serotonin (5HT3) antagonists
How it works Serotonin 3 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Not at all. Ondansetron is approved to prevent nausea and vomiting from cancer chemotherapy, radiation therapy to the abdomen or whole body, and surgery. So you might receive it be...
  • What exactly is ondansetron used for — is it just for chemo patients?
  • The regular tablet is swallowed like any other pill. The orally disintegrating tablet (ODT) is placed on your tongue and allowed to dissolve — don't chew or swallow it whole. For c...
  • How do I take the tablet or the dissolving tablet correctly?
📖 Read our full Ondansetron guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51662-1366-01 You're viewing this Main listing 2 mL in 1 VIAL 2019-12-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ondansetron 2 mg/mL 23155-0550-31 Heritage 1 vial $0.173 AP Availability likely —
Ondansetron 2 mg/mL 00641-6286-01 Hikma 20 ml $0.173 AP Availability likely —
Ondansetron 2 mg/mL 00641-6079-01 Hikma 20 ml $0.173 AP Availability likely —
Ondansetron 2 mg/mL 00409-4759-01 Hospira, 1 vial $0.173 AP Availability likely —
Ondansetron 2 mg/mL 23155-0549-31 Heritage 1 vial $0.173 AP Availability likely —
Ondansetron 2 mg/mL 72266-0124-01 Fosun 1 vial $0.173 AP Availability likely —
Ondansetron 2 mg/mL 00409-0009-25 Hospira, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00409-2271-25 Hospira, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00409-4755-03 Hospira, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00641-6078-25 Hikma 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00641-6080-25 Hikma 25 vials $0.176 AP Availability likely —
ondansetron 2 mg/mL 25021-0777-02 Sagent 25 vials $0.176 AP Availability likely —
Ondansetron Hydrochloride 2 mg/mL 36000-0012-25 Baxter 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 60505-6130-05 Apotex 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 63323-0373-02 Fresenius 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 65219-0323-02 Fresenius 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 72266-0123-25 Fosun 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 72572-0520-25 Civica, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 55150-0125-02 Eugia 25 vials $0.197 — FDA listed —
Ondansetron 2 mg/mL 00143-9891-25 West-Ward 25 vials — — FDA listed —
Ondansetron 2 mg/mL 00404-9930-02 Henry 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 23155-0547-41 Heritage 10 vials — AP FDA listed —
Ondansetron 2 mg/mL 23155-0548-41 Heritage 10 vials — AP FDA listed —
Ondansetron 2 mg/mL 50090-4935-00 A-S 25 vials — AP FDA listed —
Ondansetron 2 mg/mL 51662-1245-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mLthis 51662-1366-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 51662-1469-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 55154-2876-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 55154-2877-05 Cardinal 5 vials — AP FDA listed —
Ondansetron Hydrochloride 2 mg/mL 55154-4453-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 55154-6976-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 67184-0507-05 Qilu 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 68083-0113-01 Gland 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 71872-7068-01 Medical 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 71872-7140-01 Medical 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 71872-7162-01 Medical 1 vial — AP FDA listed —
ondansetron hydrochloride 2 mg/mL 83270-0160-03 Onesource 25 vials — — FDA listed —
Ondansetron 2 mg/mL 84549-0130-05 ProPharma 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 00143-9890-01 West-Ward 20 ml — — FDA listed —
Ondansetron 2 mg/mL 71872-7107-01 Medical 1 vial — — FDA listed —
Ondansetron 2 mg/mL 85766-0199-20 Sportpharm 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 86211-0115-01 JVET 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 51662-1377-01 HF 20 ml — AP FDA listed —
Ondansetron 2 mg/mL 68083-0114-01 Gland 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 85766-0234-25 Sportpharm 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA076972 (ANDA)
Labeler code51662
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio333 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 165 words ▾

1 INDICATIONS & USAGE

1.1Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin [see CLINICAL STUDIES (14.1)]. Ondansetron is approved for patients aged 6 months and older.

1.2Prevention of Postoperative Nausea and/or Vomiting Ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low.

For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes [see CLINICAL STUDIES (14.3)]. Ondansetron is approved for patients aged 1 month and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy Ondansetron injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration. Adults: The recommended adult intravenous dosage of ondansetron is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see CLINICAL PHARMACOLOGY (12.2)]. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy.

Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron. Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of ondansetron is three 0.15 mg/kg doses up to a maximum of 16 mg per dose [see CLINICAL STUDIES (14.1) and CLINICAL PHARMACOLOGY (12.2, 12.3)]. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy.

Subsequent doses (0.15 mg/kg up to a maximum of 16 mg per dose) are administered 4 and 8 hours after the first dose of ondansetron. The drug should be infused intravenously over 15 minutes.

2.2Prevention of Postoperative Nausea and Vomiting Ondansetron injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form. Adults: The recommended adult intravenous dosage of ondansetron is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery.

Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron 4 mg, administration of a second intravenous dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.

Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1 mg/kg dose for patients weighing 40 kg or less, or a single 4 mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic ondansetron.

2.3Stability and Handling After dilution, do not use beyond 24 hours. Although ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. Ondansetron injection is stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. Precaution: Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected.

If a precipitate is observed, resolubilize by shaking the vial vigorously.

2.4Dosage Adjustment for Patients wi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS & STRENGTHS Ondansetron injection, 2 mg per mL is a clear, colorless, nonpyrogenic, sterile solution available as a 2 mL single use vial and a 20 mL multiple dose vial.

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS Ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. Anaphylactic reactions have been reported in patients taking ondansetron [see ADVERSE REACTIONS (6.2)]. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.

5.2QT Prolongation Ondansetron prolongs the QT interval in a dose-dependent manner [see CLINICAL PHARMACOLOGY (12.2)]. In addition, postmarketing cases of Torsades de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome.

ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation.

5.3Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal.

Serotonin syndrome occurring with overdose of ondansetron alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ondansetron and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ondansetron and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron is used concomitantly with other serotonergic drugs [see DRUG INTERACTIONS (7.5), OVERDOSAGE (10) and PATIENT COUNSELING INFORMATION (17)].

5.4Masking of Progressive Ileus and Gastric Distension The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and gastric distention.

5.5Effect on Peristalsis Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The following adverse reactions have been reported in clinical trials of adult patients treated with ondansetron, the active ingredient of intravenous ondansetron across a range of dosages. A causal relationship to therapy with ondansetron was unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting: Table 1: Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15 mg/kg Doses Cardiovascular: Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. Gastrointestinal: Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron. Hepatic: In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients.

The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur. Integumentary: Rash has occurred in approximately 1% of patients receiving ondansetron.

Neurological: There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron injection, and rare cases of grand mal seizure. Other: Rare cases of hypokalemia have been reported. Postoperative Nausea and Vomiting: The adverse reactions in Table 2 have been reported in ≥ 2% of adults receiving ondansetron at a dosage of 4 mg intravenous over 2 to 5 minutes in clinical trials.

Table 2: Adverse Reactions Reported in ≥ 2% (and with Greater Frequency than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes a Adverse Reactions: Rates of these reactions were not significantly different in the ondansetron and placebo groups b Patients were receiving multiple concomitant perioperative and postoperative medications Pediatric Use: Rates of adverse reactions were similar in both the ondansetron and placebo groups in pediatric patients receiving ondansetron (a single 0.1 mg/kg dose for pediatric patients weighing 40 kg or less, or 4 mg for pediatric patients weighing more than 40 kg) administered intravenously over at least 30 seconds.

Diarrhea was seen more frequently in patients taking ondansetron (2%) compared to placebo (< 1%) in the 1 month to 24 month age group. These patients were receiving multiple concomitant perioperative and postoperative medications.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron.

Cardiovascular: Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardiographic alterations (including second-degree heart block, QT/QTc interval prolongation, and ST segment depression), palpitations, and syncope. Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT/QTc interval prolongation have been reported [see WARNINGS AND PRECAUTIONS (5.2)]. General: Flushing.

Rare cases of hyp… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

7.1Drugs Affecting Cytochrome P-450 Enzymes Ondansetron does not appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron [see CLINICAL PHARMACOLOGY (12.3)]. On the basis of limited available data, no dosage adjustment is recommended for patients on these drugs.

7.2Apomorphine Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with ondansetron is contraindicated [see CONTRAINDICATIONS (4)].

7.3Phenytoin, Carbamazepine, and Rifampin In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see CLINICAL PHARMACOLOGY (12.3)].

7.4Tramadol Although there are no data on pharmacokinetic drug interactions between ondansetron and tramadol, data from two small studies indicate that concomitant use of ondansetron may result in reduced analgesic activity of tramadol. Patients on concomitant ondansetron self administered tramadol more frequently in these studies, leading to an increased cumulative dose in patient controlled administration (PCA) of tramadol.

7.5Serotonergic Drugs Serotinin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) [see WARNINGS AND PRECAUTIONS (5.3)].

7.6Chemotherapy In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, intravenous ondansetron did not increase blood levels of high-dose methotrexate.

7.7Temazepam The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.

7.8Alfentanil and Atracurium Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at intravenous doses up to 4 mg/kg per day (approximately 1.4 and 2.9 times the recommended human intravenous dose of 0.15 mg/kg given three times a day, respectively, based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

8.3Nursing Mothers Ondansetron is excreted in the breast milk of rats. It is not known whether ondansetron is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ondansetron is administered to a nursing woman.

8.4Pediatric Use Little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month of age [see CLINICAL STUDIES (14.2)]. Little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months of age [see CLINICAL STUDIES (14.1) and DOSAGE & ADMINISTRATION (2)]. The clearance of ondansetron in pediatric patients 1 month to 4 months of age is slower and the half-life is ~2.5 fold longer than patients who are > 4 to 24 months of age.

As a precaution, it is recommended that patients less than 4 months of age receiving this drug be closely monitored [see CLINICAL PHARMACOLOGY (12.3)].

8.5Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- and foreign-controlled clinical trials, 862 were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustment is not needed in patients over the age of 65 [see CLINICAL PHARMACOLOGY (12.3)].

8.6Hepatic Impairment In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see CLINICAL PHARMACOLOGY (12.3)]. In such patients, a total daily dose of 8 mg should not be exceeded [see DOSAGE & ADMINISTRATION (2.3)].

8.7Renal Impairment Although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min), no dosage adjustment is recommended [see CLINICAL PHARMACOLOGY (12.3)].

🆘 Overdosage 205 words ▾

10 OVERDOSAGE There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events.

These doses are more than 10 times the recommended daily dose. In addition to the adverse reactions listed above, the following events have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in another patient that took 48 mg of oral ondansetron.

Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the events resolved completely. Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/kg) in young children.

Reported symptoms included somnolence, agitation, tachycardia, tachypnea, hypertension, flushing, mydriasis, diaphoresis, myoclonic movements, horizontal nystagmus, hyperreflexia, and seizure. Patients required supportive care, including intubation in some cases, with complete recovery without sequelae within 1 to 2 days.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ondansetron is a selective 5-HT3 receptor antagonist. While ondansetron’s mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

12.2Pharmacodynamics QTc interval prolongation was studied in a double blind, single intravenous dose, placebo- and positive-controlled, crossover study in 58 healthy subjects. The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline-correction was 19.5 (21.8) ms and 5.6 (7.4) ms after 15 minute intravenous infusions of 32 mg and 8 mg ondansetron, respectively. A significant exposure-response relationship was identified between ondansetron concentration and ΔΔQTcF.

Using the established exposure-response relationship, 24 mg infused intravenously over 15 min had a mean predicted (95% upper prediction interval) ΔΔQTcF of 14 (16.3) ms. In contrast, 16 mg infused intravenously over 15 min using the same model had a mean predicted (95% upper prediction interval) ΔΔQTcF of 9.1 (11.2) ms. In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time.

In another study in six normal male volunteers, a 16 mg dose infused over 5 minutes showed no effect of the drug on cardiac output, heart rate, stroke volume, blood pressure, or electrocardiogram (ECG). Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers. Ondansetron has no effect on plasma prolactin concentrations.

In a gender-balanced pharmacodynamic study (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis.

12.3Pharmacokinetics In normal adult volunteers, the following mean pharmacokinetic data have been determined following a single 0.15 mg/kg intravenous dose. Table 3: Pharmacokinetics in Normal Adult Volunteers Absorption: A study was performed in normal volunteers (n = 56) to evaluate the pharmacokinetics of a single 4 mg dose administered as a 5 minute infusion compared to a single intramuscular injection. Systemic exposure as measured by mean AUC were equivalent, with values of 156 [95% CI 136, 180] and 161 [95% CI 137, 190] ng•h/mL for intravenous and intramuscular groups, respectively.

Mean peak plasma concentrations were 42.9 [95% CI 33.8, 54.4] ng/mL at 10 minutes after intravenous infusion and 31.9 [95% CI 26.3, 38.6] ng/mL at 41 minutes after intramuscular injection. Distribution: Plasma protein binding of ondansetron as measured in vitro was 70% to 76%, over the pharmacologic concentration range of 10 to 500 ng/mL. Circulating drug also distributes into erythrocytes.

Metabolism: Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron.

The metabolites are observed in the urine. In vitro metabolism studies have shown that ondansetron is a substrate for multiple human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4. In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is apparently mediated by CYP1A2.

The role of CYP2D6 in ondansetron in vivo metabolism is relatively minor. The pharmacokinetics of intravenous ondansetron did not differ between subjects who were poor metabolizers of CYP2D6 and those who were extensive metabolizers of CYP2D6, further supporting the limited role of CYP2D6 in ondansetron disposition in vivo. Elimi… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 102 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ONDANSETRON INJECTION, USP is supplied in the following dosage forms. NDC 51662-1366-1 ONDANSETRON INJECTION, USP 4 mg/2 mL (2 mg/mL) 2 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ondansetron Injection, USP, available as a single use (preservative free) vial, is supplied as follows: Ondansetron Injection, USP, available as a multiple dose (preserved) vial, is supplied as follows: Store at 2° to 25°C (36° to 77°F).

Protect from light. The container closure is not made with natural rubber latex. HOW SUPPLIED 1 HOW SUPPLIED 2

📋 Description 185 words ▾

11 DESCRIPTION The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride dihydrate. It has the following structural formula: Ondansetron is a white to off-white powder that is sparingly soluble in water.

Each mL of the preservative-free aqueous solution in the 2 mL single use vial contains 2 mg of ondansetron as the hydrochloride; 9 mg of sodium chloride; and 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers in water for injection. Each mL of the preserved aqueous solution in the 20 mL multiple dose vial contains 2 mg of ondansetron as the hydrochloride; 8.3 mg of sodium chloride; 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers; and 1.2 mg of methylparaben and 0.15 mg of propylparaben as preservatives in water for injection.

Ondansetron Injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.0. STRUCTURE

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The clinical efficacy of ondansetron hydrochloride, the active ingredient of ondansetron, was assessed in clinical trials as described below.

14.1Chemotherapy-Induced Nausea and Vomiting Adults: In a double-blind study of three different dosing regimens of ondansetron injection, 0.015 mg/kg, 0.15 mg/kg, and 0.3 mg/kg, each given three times during the course of cancer chemotherapy, the 0.15 mg/kg dosing regimen was more effective than the 0.015 mg/kg dosing regimen. The 0.3 mg/kg dosing regimen was not shown to be more effective than the 0.15 mg/kg dosing regimen. Cisplatin-Based Chemotherapy: In a double-blind study in 28 patients, ondansetron injection (three 0.15 mg/kg doses) was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin-based chemotherapy.

Therapeutic response was as shown in Table 6. Table 6: Theraputic Response in Prevention of Chemotherapy-Induced Nausea and Vomiting in Single-Day Cisplatin Therapya in Adults a Chemotherapy was high dose (100 and 120 mg/m2; ondansetron injection n = 6, placebo n = 5) or moderate dose (50 and 80 mg/m2; ondansetron injection n = 8, placebo n = 9). Other chemotherapeutic agents included fluorouracil, doxorubicin, and cyclophosphamide.

There was no difference between treatments in the types of chemotherapy that would account for differences in response. b Efficacy based on “all patients treated” analysis. c Median undefined since at least 50% of the patients were rescued or had more than five emetic episodes. d Visual analog scale assessment of nausea: 0 = no nausea, 100 = nausea as bad as it can be. e Visual analog scale assessment of satisfaction: 0 = not at all satisfied, 100 = totally satisfied. Ondansetron injection (0.15 mg/kg x 3 doses) was compared with metoclopramide (2 mg/kg x 6 doses) in a single-blind trial in 307 patients receiving cisplatin ≥ 100 mg/m2 with or without other chemotherapeutic agents.

Patients received the first dose of ondansetron or metoclopramide 30 minutes before cisplatin. Two additional ondansetron doses were administered 4 and 8 hours later, or five additional metoclopramide doses were administered 2, 4, 7, 10, and 13 hours later. Cisplatin was administered over a period of 3 hours or less.

Episodes of vomiting and retching were tabulated over the period of 24 hours after cisplatin. The results of this study are summarized in Table 7. Table 7: Therapeutic Response in Prevention of Vomiting Induced by Cisplatin (≥ 100 mg/m2) Single-Day Therapya in Adults a In addition to cisplatin, 68% of patients received other chemotherapeutic agents, including cyclophosphamide, etoposide, and fluorouracil.

There was no difference between treatments in the types of chemotherapy that would account for differences in response. b Visual analog scale assessment: 0 = not at all satisfied, 100 = totally satisfied. Cyclophosphamide-Based Chemotherapy: In a double-blind, placebo-controlled study of ondansetron injection (three 0.15 mg/kg doses) in 20 patients receiving cyclophosphamide (500 to 600 mg/m2) chemotherapy, ondansetron injection was significantly more effective than placebo in preventing nausea and vomiting. The results are summarized in Table 8.

Table 8: Therapeutic Response in Prevention of Chemotherapy-Induced Nausea and Vomiting in Single-Day Cyclophosphamide Therapya in Adults a Chemotherapy consisted of cyclophosphamide in all patients, plus other agents, including fluorouracil, doxorubicin, methotrexate, and vincristine. There was no difference between treatments in the type of chemotherapy that would account for differences in response. b Efficacy based on “all patients treated” analysis. c Median undefined since at least 50% of patients did not have any emetic episodes. d Visual analog scale assessment of nausea: 0 = no nausea, 100 = nausea as bad as it can be. e Visual analog scale assessment of satisfaction: 0 = not at all satisfied, 100 = totally satisfied.

Re-treatment: In uncontro… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 27 words ▾

9 DRUG ABUSE AND DEPENDENCE Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

🧪 Nonclinical Toxicology 102 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 and 30 mg/kg per day, respectively (approximately 3.6 and 5.4 times the recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area). Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of ondansetron up to 15 mg/kg per day (approximately 3.8 times the recommended human intravenous dose, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.

📄 Package Label / Principal Display Panel 16 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL LABEL

PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING SERIALIZED LABELING

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ondansetron ODT (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ondansetron ODT. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$27.68M
Claims incl. refills
1.5M
Beneficiaries
1.2M
Spend / beneficiary
$23.24
Spend / claim
$18.06
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51662-1365-01 · HF 51662-1367-01 · HF →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.