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Ondansetron 4 mg Tablet, Film Coated — NDC 51662-1539-1 (Billing 51662-1539-01)

by HF Acquisition Co LLC, DBA HealthFirst · 4 BLISTER PACK in 1 BAG / 1 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Ondansetron 4 mg Tablet, Film Coated from HF Acquisition Co LLC, DBA HealthFirst, marketed since Oct 2021 and currently FDA-listed. It is this product's only package size.

NDC 51662-1539-01
🏷️ FDA NDC (as labeled) 51662-1539-1 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) 51662-1539-1
Product NDC 51662-1539
11-digit billing NDC 51662153901
RxCUI 198052
UNII NMH84OZK2B
Application # ANDA076183
SPL Set ID cdb2c4b4-a20a-3f8f-e053-2a95a90aaf72
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 2021-10-06
Route ORAL
Dosage form TABLET, FILM COATED
Substance ONDANSETRON HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 198052
Why two NDCs? The FDA registers this code as 51662-1539-1 — 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 → 51662-1539-01. 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

📖 What it is MedlinePlus · NLM

Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Read the full MedlinePlus article ↗
📗 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 · Q2 2026 $0.1854 $0.74 / 4 tablet
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
51662-1539-01 You're viewing this Main listing 4 BLISTER PACK in 1 BAG / 1 TABLET, FILM COATED in 1 BLISTER PACK 2021-10-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
ondansetron 4 mg 00904-6551-61 Major 1 tablet $0.058 AB Availability likely —
Ondansetron 4 mg 16714-0159-01 NorthStar 30 tablets $0.058 AB Availability likely —
Ondansetron Hydrochloride 4 mg 50268-0621-15 AvPAK 1 tablet $0.058 AB Availability likely —
Ondansetron Hydrochloride 4 mg 57237-0075-30 Rising 30 tablets $0.058 AB Availability likely —
Ondansetron 4 mg 62135-0350-05 Chartwell 500 tablets $0.058 AB Availability likely —
Ondansetron Hydrochloride 4 mg 65862-0187-03 Aurobindo 3 tablets $0.058 AB Availability likely —
Ondansetron Hydrochloride 4 mg 68084-0220-01 American 1 tablet $0.058 AB Availability likely —
Ondansetron 4 mg 68462-0105-30 Glenmark 30 tablets $0.058 AB Availability likely —
Ondansetron 4 mg 69339-0171-03 Natco 30 tablets $0.058 AB Availability likely —
ondansetron hydrochloride 4 mg 62756-0130-01 Sun 30 tablets $0.065 — FDA listed —
Ondansetron 4 mg 63304-0458-30 Sun 30 tablets $0.066 AB FDA listed —
ondansetron hydrochloride 4 mg 00615-8185-05 NCS 15 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 42708-0044-05 QPharma, 5 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 50090-3178-00 A-S 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 50090-6342-00 A-S 10 tablets — AB FDA listed —
Ondansetron 4 mg 51407-0003-05 Golden 500 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 51655-0415-04 Northwind 4 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 51655-0933-04 Northwind 4 tablets — AB FDA listed —
Ondansetron 4 mgthis 51662-1539-01 HF 1 tablet — AB FDA listed —
Ondansetron 4 mg 51662-1678-01 HF 30 tablets — AB FDA listed —
Ondansetron 4 mg 54348-0819-00 PharmPak, 1 tablet — AB FDA listed —
Ondansetron 4 mg 55111-0153-01 Dr. 100 tablets — AB FDA listed —
ondansetron 4 mg 55154-3551-00 Cardinal 1 tablet — AB FDA listed —
Ondansetron Hydrochloride 4 mg 55700-0631-06 Quality 6 tablets — AB Discontinued —
Ondansetron Hydrochloride 4 mg 60760-0636-10 St. 10 tablets — AB FDA listed —
Ondansetron 4 mg 61919-0565-12 Direct_Rx 12 tablets — AB Discontinued —
Ondansetron 4 mg 63187-0236-10 Proficient 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 63187-0636-01 Proficient 1 tablet — AB FDA listed —
Ondansetron 4 mg 63850-0003-01 Natco 30 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 67296-1562-03 Redpharm 3 tablets — AB Discontinued —
Ondansetron 4 mg 67296-2119-03 Redpharm 30 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 68071-2053-01 NuCare 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 68071-5047-03 NuCare 30 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 68788-8651-01 Preferred 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 68788-9368-01 Preferred 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 70518-1585-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 70518-4145-00 REMEDYREPACK 16 tablets — AB FDA listed —
Ondansetron 4 mg 70518-4588-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ondansetron 4 mg 71335-0132-00 Bryant 60 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 71335-0205-00 Bryant 60 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 71335-1855-00 Bryant 60 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 72162-2364-05 Bryant 500 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 72789-0034-12 PD-Rx 12 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 76420-0915-00 Asclemed 1000 tablets — AB FDA listed —
Ondansetron HCL 4 mg 80425-0072-01 Advanced 20 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 82804-0257-10 Proficient 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 83008-0074-20 Quality 20 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 85509-1057-04 PHOENIX 12 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 85509-1075-01 PHOENIX 10 tablets — AB FDA listed —
Ondansetron Hydrochloride 4 mg 85766-0006-00 Sportpharm 1000 tablets — AB 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

What it looks like

Color white
ShapeRound
ImprintR;153
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 holderDR REDDYS LABORATORIES LTD
FDA applicationANDA076183 (ANDA)
Labeler code51662
First marketedOct 2021
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 73 words ▾

1 INDICATIONS AND USAGE 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/m2 . 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.

⏱️ Dosage and Administration 73 words ▾

2 DOSAGE AND ADMINISTRATION

2.1Dosage The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Corresponding doses of ondansetron tablets may be used interchangeably.

2.2Dosage in Hepatic Impairment In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see Use in Specific Populations (8.6 ), Clinical Pharmacology ( 12.3 )]. DOSAGE

💊 Dosage Forms and Strengths 129 words ▾

3 DOSAGE FORMS AND STRENGTHS Ondansetron tablets USP, 4 mg (ondansetron hydrochloride USP, equivalent to 4 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “153” on other side. Ondansetron tablets USP, 8 mg (ondansetron hydrochloride USP, equivalent to 8 mg of ondansetron) are yellow, round, biconvex, film coated tablets debossed “R” on one side and “154” on other side. Ondansetron tablets USP, 16 mg (ondansetron hydrochloride USP, equivalent to 16 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “155” on other side.

Ondansetron tablets USP, 24 mg (ondansetron hydrochloride USP, equivalent to 24 mg of ondansetron) are pink, round, biconvex, film coated tablets debossed “R” on one side and “156” on other side.

⛔ Contraindications 45 words ▾

4 CONTRAINDICATIONS Ondansetron is contraindicated in patients: 1. known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions ( 6.2 )] 2. receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness

⚠️ 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. If hypersensitivity reactions occur, discontinue use of ondansetron; treat promptly per standard of care and monitor until signs and symptoms resolve [see Contraindications ( 4 )].

5.2QT Prolongation Electrocardiogram (ECG) changes including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade 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 [see Clinical Pharmacology ( 12.2 )].

5.3Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone. 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 ( 7.1 ), Overdosage ( 10 )].

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/or gastric distension. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron. A causal relationship to therapy with ondansetron was unclear in many cases.

Prevention of Chemotherapy-Induced Nausea and Vomiting The most common adverse reactions reported in greater than or equal to 4% of 300 adults receiving a single 24 mg dose of ondansetron orally in 2 trials for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy (cisplatin greater than or equal to 50 mg/m2) were: headache (11%) and diarrhea (4%). The most common adverse reactions reported in 4 trials in adults for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy (primarily cyclophosphamide-based regimens) are shown in Table 3.

Table 3: Most Common Adverse Reactions in Adultsa for the Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy [Primarily Cyclophosphamide-based Regimens] a Reported in greater than or equal to 5% of patients treated with ondansetron and at a rate that exceeded placebo. Less Common Adverse Reactions Central Nervous System: Extrapyramidal reactions (less than 1% of patients). Hepatic: Aspartate transaminase (AST) and/or alanine transaminase (ALT) values exceeded twice the upper limit of normal in approximately 1% to 2% of 723 patients receiving ondansetron and cyclophosphamide-based chemotherapy in US clinical trials.

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. The role of cancer chemotherapy in these biochemical changes is unclear.

Liver failure and death has been reported in cancer patients receiving concurrent medications, including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Integumentary: Rash (approximately 1% of patients).

Other (less than 2%): Anaphylaxis, bronchospasm, tachycardia, angina, hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures. Except for bronchospasm and anaphylaxis, the relationship to ondansetron is unclear. Prevention of Radiation-Induced Nausea and Vomiting The most common adverse reactions (greater than or equal to 2%) reported in patients receiving ondansetron and concurrent radiotherapy were similar to those reported in patients receiving ondansetron and concurrent chemotherapy and were headache, constipation, and diarrhea.

Prevention of Postoperative Nausea and Vomiting The most common adverse reactions reported in adults in trial(s), of prevention of postoperative nausea and vomiting are shown in Table 4. In these trial(s) patients were receiving multiple concomitant perioperative and postoperative medications in both treatment groups. Table 4: Most Common Adverse Reactions in Adultsa for the Prevention of Postoperative Nausea and Vomiting a Reported in greater than or equal to 5% of patients treated with ondansetron and at a rate that exceeded placebo.

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. Cardiovascular Arrhythmias (including ventricular and supraventricular tachycardia, premature ventricular contractions, and atrial fibrillation), bradycardia, electrocardi… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS

7.1Serotonergic Drugs Serotonin 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). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue ondansetron and initiate supportive treatment [see Warnings and Precautions ( 5.3 )].

7.2Drugs Affecting Cytochrome P-450 Enzymes Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver [see Clinical Pharmacology (12.3)]. 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. 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 )].

7.3Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small trials indicate that when used together, ondansetron may increase patient-controlled administration of tramadol. Monitor patients to ensure adequate pain control when ondansetron is administered with tramadol.

7.4Chemotherapy Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic concentrations of high-dose methotrexate.

7.5Alfentanil 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 ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data do not reliably inform the association of ondansetron and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation (see Data). Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see Data].

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy.

Two large retrospective cohort studies of ondansetron use in pregnancy have been published. In one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. In this same study, however, a sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defect (odds ratio (OR) 1.62 [95% CI (1.04, 2.14)]) and cardiac septal defect (OR 2.05 [95% CI (1.19, 3.28)]).

The second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage or stillbirth, and infants of low-birth weight or small for gestational age. Important methodological limitations with these studies include the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings.

A case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted OR = 2.37 [95% CI (1.18, 4.76)]). However, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy) or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring.

In addition, no cases of isolated cleft palate were identified in the aforementioned 2 large retrospective cohort studies. At this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate. Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis.

With the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. At doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on body surface area. In a pre-and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from Day 17 of pregnancy to litter Day 21.

With the exception o… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 172 words ▾

10 OVERDOSAGE There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. In addition to the adverse reactions listed above, the following adverse reactions 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 a patient that took 48 mg of ondansetron tablets. 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 adverse reactions resolved completely.

Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg per 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 ~2 min read ▾

12 CLINICAL PHARMACOLOGY The molecular formula is C18H19N3O•HCl•2H2O, representing a molecular weight of 365.86. Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron.

Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron.

Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide. Renal Impairment: Renal impairment is not expected to significantly influence the total clearance of ondansetron as renal clearance represents only 5% of the overall clearance.

However, the mean plasma clearance of ondansetron was reduced by about 50% in patients with severe renal impairment (creatinine clearance less than 30 mL/min). The reduction in clearance was variable and not consistent with an increase in half-life [see Use in Specific Populations ( 8.7 )]. Hepatic Impairment: In patients with mild-to-moderate hepatic impairment, clearance is reduced 2-fold and mean half-life is increased to 11.6 hours compared with 5.7 hours in healthy subjects.

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced 2-fold to 3-fold and apparent volume of distribution is increased with a resultant increase in half-life to 20 hours [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.6) ]. Drug Interaction Studies CYP 3A4 Inducers: Ondansetron elimination may be affected by cytochrome P-450 inducers. In a pharmacokinetic trial of 16 epileptic patients maintained chronically on CYP3A4 inducers, carbamazepine, or phenytoin, a reduction in AUC, Cmax, and t½ of ondansetron was observed.

This resulted in a significant increase in the clearance of ondansetron. However, this increase is not thought to be clinically relevant [see Drug Interactions ( 7.2 )]. Chemotherapeutic Agents: Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron [see Drug Interactions (7.4 )].

Antacids: Concomitant administration of antacids does not alter the absorption of ondansetron. CP

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron Tablets Ondansetron tablets USP, 4 mg (ondansetron hydrochloride USP, equivalent to 4 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “153” on other side and are supplied in the following dosage forms. NDC 51662-1539-1 ONDANSETRON TABLETS USP 4mg* (4 PACK) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ondansetron Tablets Ondansetron tablets USP, 4 mg (ondansetron hydrochloride USP, equivalent to 4 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “153” on other side and are supplied in bottles of 30, 100, 500, unit-dose packages of 100 (10 x 10) and unit-dose packages of 3 (1 x 3).

Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6551-61 Ondansetron tablets USP, 8 mg (ondansetron hydrochloride USP, equivalent to 8 mg of ondansetron) are yellow, round, biconvex, film coated tablets debossed “R” on one side and “154” on other side and are supplied in bottles of 30, 100, 500, unit-dose packages of 100 (10 x 10) and unit-dose packages of 3 (1 x 3). Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6552-61 Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).

Dispense in tight container as defined in the USP. Store blisters in cartons.

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, 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: The molecular formula is C18H19N3O•HCl•2H2O, representing a molecular weight of 365.86.

Ondansetron HCl dihydrate USP is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron.

Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate USP equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide.

STRUCTURE

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Prevention of Chemotherapy-Induced Nausea and Vomiting Highly Emetogenic Chemotherapy In 2 randomized, double-blind, monotherapy trials, a single 24 mg oral dose of ondansetron was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. Steroid administration was excluded from these clinical trials. More than 90% of patients receiving a cisplatin dose greater than or equal to 50 mg/m2 in the historical placebo comparator, experienced vomiting in the absence of antiemetic therapy.

The first trial compared oral doses of ondansetron 24 mg as a single dose, 8 mg every 8 hours for 2 doses, and 32 mg as a single dose in 357 adult cancer patients receiving chemotherapy regimens containing cisplatin greater than or equal to 50 mg/m2. The first or single dose was administered 30 minutes prior to chemotherapy. A total of 66% of patients in the ondansetron 24 mg once-a-day group, 55% in the ondansetron 8 mg twice-a-day group, and 55% in the ondansetron 32 mg once-a-day group, completed the 24 hour trial period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy.

Each of the 3 treatment groups was shown to be statistically significantly superior to a historical placebo control. In the same trial, 56% of patients receiving a single 24 mg oral dose of ondansetron experienced no nausea during the 24 hour trial period, compared with 36% of patients in the oral ondansetron 8 mg twice-a-day group (P = 0.001) and 50% in the oral ondansetron 32 mg once-a-day group. Dosage regimens of ondansetron 8 mg twice daily and 32 mg once daily are not recommended for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy [see Dosage and Administration (2.1)].

In a second trial, efficacy of a single 24 mg oral dose of ondansetron for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2, was confirmed. Moderately Emetogenic Chemotherapy A randomized, placebo-controlled, double-blind trial was conducted in the US in 67 patients receiving a cyclophosphamide-based chemotherapy regimen containing doxorubicin. The first 8 mg dose of ondansetron was administered 30 minutes before the start of chemotherapy, with a subsequent dose 8 hours after the first dose, followed by 8 mg of ondansetron twice a day for 2 days after the completion of chemotherapy.

Ondansetron was significantly more effective than placebo in preventing vomiting. Treatment response was based on the total number of emetic episodes over the 3 day trial period. The results of this trial are summarized in Table 7: Table 7: Emetic Episodes-Treatment Response in Patients Receiving Moderately Emetogenic Chemotherapy (Cyclophosphamide-based Regimen Containing Doxorubicin) a Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes. b Median undefined since at least 50% of patients did not have any emetic episodes.

In a double-blind, US trial in 336 patients receiving a cyclophosphamide-based chemotherapy regimen containing either methotrexate or doxorubicin, ondansetron 8 mg administered twice a day, was as effective as ondansetron 8 mg administered 3 times a day in preventing nausea and vomiting. ondansetron 8 mg three times daily is not a recommended regimen for the treatment of moderately emetogenic chemotherapy [see Dosage and Administration (2.1 )]. Treatment response was based on the total number of emetic episodes over the 3 day trial period.

See Table 8 for the details of the dosage regimens studied and results of this trial. Table 8: Emetic Episodes-Treatment Response after Ondansetron Tablets Administered Twice a Day and Three Times a Day a The first 8 mg dose was administered 30 minutes before the start of emetogenic chemo… [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 110 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 mg/kg per day and 30 mg/kg per day, respectively (approximately 4 and 6 times the maximum recommended human oral dose of 24 mg per 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 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area) did not affect fertility or general reproductive performance of male and female rats.

📄 Package Label / Principal Display Panel 26 words ▾

PRINCIPAL DISPLAY PANEL - 51662-1539-1 ONDANSETRON TABLETS USP 4mg* (4 PACK) 51662-1539-1 Ondansetron Tablets USP 4 mg* (4 PACK) TABLET LABELING RFID Label BAG BACK 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 — Not published for this NDC No photo available yet for this listing.
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.
← 51662-1538-01 · HF 51662-1540-01 · 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.