What this pack is
ZOFRAN / ZOFRAN ODT is the brand name in this record; ondansetron is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
ZOFRAN / ZOFRAN ODTGeneric nameondansetron
How this medicine works
The official label describes ondansetron as a selective 5-HT3 receptor antagonist, explaining an antiemetic pharmacologic pathway. Mechanism does not diagnose the cause of nausea or vomiting or derive individual suitability, tablet count, millilitres or combination with another antiemetic.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- ZOFRAN / ZOFRAN ODT
- Source-scoped market brand names
- ZOFRAN / ZOFRAN ODT · United StatesSource-scoped evidence ↗The current 2025 approved label is readable; six oral Orange Book RLD products are currently listed as Discontinued, which does not establish stock.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- ondansetron
- Dosage-form class
- Conventional oral tablets, orally disintegrating tablets and 4 mg/5 mL oral solution must be identified separately. The 24 mg conventional tablet is an historical Orange Book product identity and is not listed among the available dosage forms and strengths in the current 2025 label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
6 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025
Ondansetron 4 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020103 / Product 001
- Form and route
- ZOFRAN ondansetron conventional oral tablet (historical RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ondansetron (as ondansetron hydrochloride dihydrate)
- 4 mgregulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction
United States label · Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025
Ondansetron 8 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020103 / Product 002
- Form and route
- ZOFRAN ondansetron conventional oral tablet (historical RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ondansetron (as ondansetron hydrochloride dihydrate)
- 8 mgregulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction
United States label · Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025
Ondansetron 24 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020103 / Product 003
- Form and route
- ZOFRAN ondansetron conventional oral tablet (historical RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ondansetron (as ondansetron hydrochloride dihydrate)
- 24 mgregulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction
United States label · Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists this form and strength
Ondansetron 4 mg per orally disintegrating tablet; historical RLD currently listed as Discontinued in the Orange Book
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020781 / Product 001
- Form and route
- ZOFRAN ODT ondansetron orally disintegrating tablet (historical RLD) · oral / disintegrates on the tongue (historical regulatory product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ondansetron (as ondansetron hydrochloride dihydrate)
- 4 mgregulatory amount per tablet; not an individual's tablet count, frequency, administration or conversion instruction
United States label · Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists this form and strength
Ondansetron 8 mg per orally disintegrating tablet; historical RLD currently listed as Discontinued in the Orange Book
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020781 / Product 002
- Form and route
- ZOFRAN ODT ondansetron orally disintegrating tablet (historical RLD) · oral / disintegrates on the tongue (historical regulatory product-identity field)
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ondansetron (as ondansetron hydrochloride dihydrate)
- 8 mgregulatory amount per tablet; not an individual's tablet count, frequency, administration or conversion instruction
United States label · Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists 4 mg/5 mL
Ondansetron 4 mg per 5 mL; this is a concentration, not an individual's millilitres
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020605 / Product 001
- Form and route
- ZOFRAN ondansetron oral solution (historical RLD) · oral (historical regulatory product-identity field)
- Labelled concentration
- ondansetron 4 mg/5 mLProduct identity, not an individual dose
- Listing review
- Cited public label display reviewed 2026-08-29; actual marketing, stock and availability are not established.
- ondansetron (as ondansetron hydrochloride dihydrate)
- 4 mgregulatory concentration per 5 mL; not an individual's millilitres, frequency or course
PACKAGE-VISUAL STATUS
Six official text product identities are established; exact public principal-display images are not yet mapped one-to-one
The Orange Book verifies three NDAs, six product numbers, forms, strengths, RLD identity and discontinued status, but the reviewed official sources do not supply safely reusable exact originator-brand principal-display images mapped one-to-one to all six identities. The page discloses the image gap and does not substitute a generic, retail image, injection or another dosage form.
LABEL READING · NOT A PRESCRIPTION
ZOFRAN label reading: distinguish conventional tablets, ODTs, oral solution and full-list risks first
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The 2025 FDA label covers conventional tablets, orally disintegrating tablets and 4 mg/5 mL oral solution. This page enlarges product identity, handling and priority review cues; it does not decide individual use or generate tablet count, millilitres, frequency, missed-use action, initiation, stopping or course.
- Conventional tablets and ODTs may both say 4 mg or 8 mg, but their dosage form and handling differ. Keep ZOFRAN ODT in its blister until use, peel back the foil with dry hands, gently remove it rather than push the fragile tablet through the foil, and place it on the tongue immediately to dissolve. This is not an individual frequency or dosage-form switching rule.
- ZOFRAN ODT contains aspartame and supplies a small amount of phenylalanine. A person with phenylketonuria or a caregiver should verify the exact form and current label; conventional-tablet or solution information does not replace this ODT ingredient warning.
- The label warns about QT prolongation. Avoid use in congenital long-QT syndrome; low potassium or magnesium, congestive heart failure, bradyarrhythmia or another QT-prolonging medicine requires professional review and the label may call for ECG monitoring. Do not add, reduce, separate or stop any medicine from this page.
- Serotonin syndrome may occur with serotonergic medicines, including some SSRIs, SNRIs, other antidepressants, triptans, tramadol, lithium, fentanyl and St John's wort. A combination of agitation, mental-status change, rapid heartbeat, blood-pressure change, fever, sweating, tremor, muscle rigidity or diarrhoea needs immediate medical assessment; use local emergency services if severe.
- Apomorphine with ondansetron is contraindicated in the label because profound hypotension and loss of consciousness have been reported. If both appear on the medicine list, do not self-try, separate or stop/switch them; contact the prescriber or pharmacist promptly.
- Severe chest pain, breathing difficulty, fainting or an abnormal rhythm may require emergency care. Persistent constipation, abdominal distension, vomiting or suspected obstruction also needs prompt assessment because ondansetron may mask progressive ileus or gastric distension. The site does not diagnose the cause or arrange individual use.
- Oral solution 4 mg/5 mL is a concentration and does not mean everyone uses 5 mL. Individual millilitres, measuring device, frequency and course must come from the exact prescription and pharmacy label; an ordinary kitchen spoon is not a reliable measure.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-29
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeU.S. FDA: current approved ZOFRAN ondansetron tablet, orally disintegrating tablet and oral-solution label (revised Feb 2025) ↗Current regulatory record · reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29U.S. FDA: historical approved ZOFRAN tablet, orally disintegrating tablet and oral-solution label (2016) ↗Historical public record · reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about ZOFRAN / ZOFRAN ODT (ondansetron). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
ZOFRAN / ZOFRAN ODT is the brand in this record and ondansetron is the active-ingredient name. Check both with the dosage form (Conventional oral tablets, orally disintegrating tablets and 4 mg/5 mL oral solution must be identified separately. The 24 mg conventional tablet is an historical Orange Book product identity and is not listed among the available dosage forms and strengths in the current 2025 label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- U.S. FDA: current approved ZOFRAN ondansetron tablet, orally disintegrating tablet and oral-solution label (revised Feb 2025) ↗Current regulatory record · reviewed 2026-08-29
- Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗reviewed 2026-08-29
- U.S. FDA: historical approved ZOFRAN tablet, orally disintegrating tablet and oral-solution label (2016) ↗Historical public record · reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How ondansetron works: 5-HT3 receptor antagonism is not an individual selection or switching rule
- An antiemetic class cannot replace assessment for dehydration, infection, obstruction, adverse drug effects, cardiac problems or another cause; persistent or severe symptoms need local medical support.
- Being an antiemetic or affecting serotonin does not make it self-combinable, substitutable or milligram-convertible with metoclopramide, another 5-HT3 antagonist or a psychiatric medicine.
- Mechanism does not remove the labelled risks of QT prolongation, serotonin syndrome, the apomorphine contraindication or masking obstruction; the complete medicine list, exact product and actual symptoms must be reviewed together.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- U.S. FDA: current approved ZOFRAN ondansetron tablet, orally disintegrating tablet and oral-solution label (revised Feb 2025) ↗Current regulatory record · reviewed 2026-08-29
- Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗reviewed 2026-08-29
- U.S. FDA: historical approved ZOFRAN tablet, orally disintegrating tablet and oral-solution label (2016) ↗Historical public record · reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
ZOFRAN / ZOFRAN ODTondansetron
This page links to public primary-source material for ZOFRAN / ZOFRAN ODT. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. ZOFRAN approval milestone
The current 2025 FDA label lists 1991 as the initial U.S. approval year; this dossier's product cards cover only the six later oral identities.
U.S. FDA: current approved ZOFRAN ondansetron tablet, orally disintegrating tablet and oral-solution label (revised Feb 2025) ↗ZOFRAN 4 mg and 8 mg conventional tablets
The Orange Book lists NDA 020103 products 001 and 002 as RLDs; their current product status is Discontinued.
Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗ZOFRAN 4 mg/5 mL oral solution
The Orange Book lists NDA 020605 product 001 as an RLD; its current product status is Discontinued.
Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗ZOFRAN ODT and the historical 24 mg conventional tablet
The 4/8 mg ODTs were approved on 27 Jan 1999 and the 24 mg conventional tablet on 27 Aug 1999. All three are currently listed as Discontinued; 24 mg is not in the current 2025 label's available dosage-form and strength list.
Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗Current approved oral label revised
The current FDA label provides product information and safety boundaries for 4/8 mg conventional tablets, 4/8 mg ODTs and 4 mg/5 mL oral solution. A readable label does not establish current supply of the six historical RLD products.
U.S. FDA: current approved ZOFRAN ondansetron tablet, orally disintegrating tablet and oral-solution label (revised Feb 2025) ↗Orange Book status reviewed
All six oral products are RLDs, RS No and currently listed as Discontinued; the data retain the determination that they were not discontinued or withdrawn for safety or effectiveness reasons.
Current U.S. FDA Orange Book data: six oral ZOFRAN RLD products and their discontinued status ↗
MARKET SCOPE
Market-record boundary
United States
Current 2025 approved label readable; six specific oral RLD products currently listed as DiscontinuedThese states must be read separately and do not establish stock, a purchasing channel, individual suitability or interchangeability.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, shared ingredient or milligram numbers.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Can a 4 mg ZOFRAN ODT and a 4 mg conventional tablet be directly interchanged?
Do not self-switch from the shared ingredient and milligram number. They are different dosage forms with different handling and excipient cues; verify the exact prescription, product in hand and current local label with a pharmacist or prescriber.
Does oral solution 4 mg/5 mL mean taking 5 mL every time?
No. 4 mg/5 mL is a concentration, not an individual dose. Individual millilitres, frequency and course must come from the exact prescription and pharmacy label and be measured with a suitable oral device.
Can the site decide whether ZOFRAN can be used with my antidepressant or rhythm-affecting medicine?
No. The ondansetron label includes serotonin-syndrome and QT-prolongation risks. Review requires exact names/forms, reasons, conditions, electrolytes and the full list. Ask a clinician or pharmacist to review each item; use local emergency services for severe symptoms.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.