Ondansetron
Tablet, Orally Disintegrating · Oral, Intramuscular, Intravenous
Uses
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. 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 where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
Dosage and administration
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m 2 . Multiday, single-dose administration of a 24 mg dosage has not been studied. Pediatric Use There is no experience with the use of a 24 mg dosage in pediatric patients. Geriatric Use The dosage recommendation is the same as for the general population. Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy The recommended adult oral dosage is one 8 mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Pediatric Use For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron tablet or one 4 mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. Geriatric Use The dosage is the same as for the general population. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen The recommended oral dosage is one 8 mg ondansetron tablet given 3 times a day. For total body irradiation, one 8 mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given. Pediatric Use There is no experience with the use of ondansetron tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients. Geriatric Use The dosage recommendation is the same as for the general population. Postoperative Nausea and Vomiting The recommended dosage is 16 mg given as two 8 mg ondansetron tablets 1 hour before induction of anesthesia. Pediatric Use There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients. Geriatric Use The dosage is the same as for the general population. Dosage Adjustment for Patients With Impaired Renal Function The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron. Dosage Adjustment for Patients With Impaired Hepatic Function In patients with severe hepatic impairment (Child-Pugh 2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
Contraindications
The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorhpine was administered with ondansetron. Ondansetron tablets are contraindicated for patients known to have hypersensitivity to the drug.
Warnings
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron hydrochloride 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.
Precautions
General Ondansetron is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of nasogastric suction. 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. Drug Interactions Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). 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. On the basis of available data, no dosage adjustment is recommended for patients on these drugs. Apomorphine Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see CONTRAINDICATIONS ). Phenytoin, Carbamazepine, and Rifampicin In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), 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. 1, 3 Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol. 4, 5 Chemotherapy Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate. Use in Surgical Patients: The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam. Carcinogenesis, 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/day, respectively. Ondansetron was not mutagenic in standard tests for mutagenicity. Oral administration of ondansetron up to 15 mg/kg/day did not affect fertility or general reproductive performance of male and female rats. Pregnancy Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, 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. Nursing 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. Pediatric Use Little information is available about dosage in pediatric patients 4 years of age or younger (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION sections for use in pediatric patients 4 to 18 years of age) Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 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 ).
Side effects
The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron tablets. A causal relationship to therapy with ondansetron tablets have been unclear in many cases. Chemotherapy-Induced Nausea and Vomiting The adverse events in Table 5 have been reported in ≥ 5% of adult patients receiving a single 24 mg ondansetron tablet in 2 trials. These patients were receiving concurrent highly emetogenic cisplatin-based chemotherapy regimens (cisplatin dose ≥ 50 mg/m 2 ). Table 5. Principal Adverse Events in US Trials: Single Day Therapy With 24-mg Ondansetron hydrochloride tablets (Highly Emetogenic Chemotherapy) Event Ondansetron 24 mg q.d. n = 300 Ondansetron 8 mg b.i.d. n = 124 Ondansetron 32 mg q.d. n = 117 Headache 33 (11%) 16 (13%) 17 (15%) Diarrhea 13 (4%) 9 (7%) 3 (3%) The adverse events in Table 6 have been reported in ≥ 5% of adults receiving either 8 mg of ondansetron tablets 2 or 3 times a day for 3 days or placebo in 4 trials. These patients were receiving concurrent moderately emetogenic chemotherapy, primarily cyclophosphamide-based regimens. Table 6. Principal Adverse Events in US Trials: 3 Days of Therapy With 8 mg Ondansetron tablets (Moderately Emetogenic Chemotherapy) Event Ondansetron 8 mg b.i.d. n = 242 Ondansetron 8 mg t.i.d. n = 415 Placebo n = 262 Headache 58 (24%) 113 (27%) 34 (13%) Malaise/fatigue 32 (13%) 37 (9%) 6 (2%) Constipation 22 (9%) 26 (6%) 1 (<1%) Diarrhea 15 (6%) 16 (4%) 10 (4%) Dizziness 13 (5%) 18 (4%) 12 (5%) Central Nervous System There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving ondansetron. Hepatic In 723 patients receiving cyclophosphamide-based chemotherapy in US clinical trials, AST and/or ALT values have been reported to exceed twice the upper limit of normal in approximately 1% to 2% of patients receiving ondansetron tablets. 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 cannot be clearly determined. There have been reports of liver failure and death in patients with cancer receiving concurrent medications including potentially hepatotoxic cytotoxic chemotherapy and antibiotics. The etiology of the liver failure is unclear. Integumentary Rash has occurred in approximately 1% of patients receiving ondansetron. Other Rare cases of anaphylaxis, bronchospasm, tachycardia, angina (chest pain), hypokalemia, electrocardiographic alterations, vascular occlusive events, and grand mal seizures have been reported. Except for bronchospasm and anaphylaxis, the relationship to ondansetron tablets was unclear. Radiation-Induced Nausea and Vomiting The adverse events reported in patients receiving ondansetron tablets and concurrent radiotherapy were similar to those reported in patients receiving ondansetron tablets and concurrent chemotherapy. The most frequently reported adverse events were headache, constipation, and diarrhea. Postoperative Nausea and Vomiting The adverse events in Table 7 have been reported in ≥ 5% of patients receiving ondansetron tablets at a dosage of 16 mg orally in clinical trials. With the exception of headache, rates of these events were not significantly different in the ondansetron and placebo groups. These patients were receiving multiple concomitant perioperative and postoperative medications. Table 7. Frequency of Adverse Events From Controlled Studies With Ondansetron tablets (Postoperative Nausea and Vomiting) Adverse Event Ondansetron 16 mg (n = 550) Placebo (n = 531) Wound problem 152 (28%) 162 (31%) Drowsiness/sedation 112 (20%) 122 (23%) Headache 49 (9%) 27 (5%) Hypoxia 49 (9%) 35 (7%) Pyrexia 45 (8%) 34 (6%) Dizziness 36 (7%) 34 (6%) Gynecological disorder 36 (7%) 33 (6%) Anxiety/agitation 33 (6%) 29 (5%) Bradycardia 32 (6%) 30 (6%) Shiver(s) 28 (5%) 30 (6%) Urinary retention 28 (5%) 18 (3%) Hypotension 27 (5%) 32 (6%) Pruritus 27 (5%) 20 (4%) Observed During Clinical Practice In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of oral formulations of ondansetron tablets. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ondansetron tablets. Cardiovascular Rarely and predominantly with intravenous ondansetron, transient ECG changes including QT interval prlongation have been reported. General Flushing. Rare cases of hypersensitivity reactions, sometimes severe (e.g., anaphylaxis/anaphylactoid reactions, angioedema, bronchospasm, shortness of breath, hypotension, laryngeal edema, stridor) have also been reported. Laryngospasm, shock, and cardiopulmonary arrest have occurred during allergic reactions in patients receiving injectable ondansetron. Hepatobiliary Liver enzyme abnormalities Lower Respiratory Hiccups Neurology Oculogyric crisis, appearing alone, as well as with other dystonic reactions Skin Urticaria Special Senses Eye Disorders Cases of transient blindness, predominantly during intravenous administration, have been reported. These cases of transient blindness were reported to resolve within a few minutes up to 48 hours.
Drug interactions
Drug Interactions Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see CLINICAL PHARMACOLOGY, Pharmacokinetics ). 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. On the basis of available data, no dosage adjustment is recommended for patients on these drugs. Apomorphine Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see CONTRAINDICATIONS ). Phenytoin, Carbamazepine, and Rifampicin In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), 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. 1, 3 Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol. 4, 5 Chemotherapy Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate. Use in Surgical Patients: The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.
Pregnancy
Pregnancy Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at daily oral doses up to 15 and 30 mg/kg/day, respectively, 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.
Pediatric use
Pediatric Use Little information is available about dosage in pediatric patients 4 years of age or younger (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION sections for use in pediatric patients 4 to 18 years of age)
Geriatric use
Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in US- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 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 ).
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 events 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 1 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 events resolved completely.
Description
The active ingredient in ondansetron is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 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 empirical formula is C 18 H 19 N 3 O·HCl·2H 2 O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). This product meets USP Dissolution Test 3. Chemical-structure
How supplied
Ondansetron tablets USP, 4 mg (ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets debossed with “4” on one side and “NO” on the other side. They are supplied as follows: NDC 67877-169-30 Bottles of 30 Ondansetron tablets USP, 8 mg (ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets, debossed with “8” on one side and “NO” on the other side. They are supplied as follows: NDC 67877-170-30 Bottles of 30 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Label text from the FDA structured product label by Ascend Laboratories, LLC (revised Jul 22, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ondansetron in 99 products
- Ondansetron Hydrochloride in 93 products
Ondansetron NDC products (192)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-4935 | Ondansetron Hydrochloride 2 mg/mL Injection | A-S Medication Solutions | ANDA |
| 50090-4632 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 50090-2343 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 50090-1659 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 50090-1658 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 50090-1201 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 50090-1200 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 50090-1128 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | A-S Medication Solutions | ANDA |
| 16729-298 | Ondansetron 2 mg/mL Injection | Accord Healthcare, Inc. | ANDA |
| 80425-0073 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0473 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0469 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0227 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0228 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0222 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 60687-252 | Ondansetron Hydrochloride 4 mg/5mL Solution | American Health Packaging | ANDA |
| 65162-691 | Ondansetron Hydrochloride 4 mg/5mL Solution | Amneal Pharmaceuticals LLC | ANDA |
| 60505-6130 | Ondansetron Hydrochloride 2 mg/mL Injection | Apotex Corp. | ANDA |
| 67877-170 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Ascend Laboratories, LLC | ANDA |
| 76420-251 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Asclemed USA, Inc. | ANDA |
| 76420-217 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Asclemed USA, Inc. | ANDA |
| 76420-056 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Asclemed USA, Inc. | ANDA |
| 17856-0691 | Ondansetron Hydrochloride 4 mg/5mL Solution | ATLANTIC BIOLOGICALS CORP. | ANDA |
| 17856-0672 | Ondansetron Hydrochloride 4 mg/5mL Solution | Atlantic Biologics Corp. | ANDA |
| 65862-391 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Aurobindo Pharma Limited | ANDA |
| 65862-390 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Aurobindo Pharma Limited | ANDA |
| 65862-208 | Ondansetron Hydrochloride 4 mg/5mL Solution | Aurobindo Pharma Limited | ANDA |
| 42291-457 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | AvKARE | ANDA |
| 42291-458 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | AvKARE | ANDA |
| 50268-647 | Ondansetron Hydrochloride 4 mg/5mL Solution | AvPAK | ANDA |
| 68001-247 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | BluePoint Laboratories | ANDA |
| 68001-246 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | BluePoint Laboratories | ANDA |
| 71335-0650 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-2974 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-0815 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1071 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-1314 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-1731 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-2635 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-2972 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-0132 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-9726 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-3073 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 63629-4306 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 71335-2973 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Bryant Ranch Prepack | ANDA |
| 55154-6976 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Cardinal Health 107, LLC | ANDA |
| 55154-2876 | Ondansetron Hydrochloride 2 mg/mL Injection | Cardinal Health 107, LLC | ANDA |
| 55154-2877 | Ondansetron Hydrochloride 2 mg/mL Injection | Cardinal Health 107, LLC | ANDA |
| 55154-3551 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-3680 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Cardinal Health 107, LLC | ANDA |
| 55154-4567 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Cardinal Health 107, LLC | ANDA |
| 55154-7879 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-8339 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Cardinal Health 107, LLC | ANDA |
| 62135-879 | Ondansetron 24 mg/1 Tablet, Orally Disintegrating | Chartwell RX, LLC | ANDA |
| 62135-878 | Ondansetron 16 mg/1 Tablet, Orally Disintegrating | Chartwell RX, LLC | ANDA |
| 62135-351 | Ondansetron Hydrochloride 8 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-350 | Ondansetron Hydrochloride 4 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-122 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Chartwell RX, LLC | ANDA |
| 62135-121 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Chartwell RX, LLC | ANDA |
| 72572-520 | Ondansetron Hydrochloride 2 mg/mL Injection | Civica, Inc. | ANDA |
| 61919-986 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Direct Rx | ANDA |
| 61919-565 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 55111-156 | Ondansetron Hydrochloride 24 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-154 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-153 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55150-126 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Eugia US LLC | ANDA |
| 55150-125 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Eugia US LLC | ANDA |
| 72266-124 | Ondansetron Hydrochloride 2 mg/mL Injection | Fosun Pharma USA Inc. | ANDA |
| 72266-123 | Ondansetron Hydrochloride 2 mg/mL Injection | Fosun Pharma USA Inc. | ANDA |
| 76045-216 | Ondansetron Hydrochloride 4 mg/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA |
| 76045-103 | Ondansetron Hydrochloride 4 mg/2mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-373 | Ondansetron Hydrochloride 2 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 63323-374 | Ondansetron Hydrochloride 2 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 65219-323 | Ondansetron Hydrochloride 2 mg/mL Injection | Fresenius Kabi USA, LLC | ANDA |
| 68083-113 | Ondansetron Hydrochloride 2 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68083-114 | Ondansetron Hydrochloride 2 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68462-105 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-106 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-157 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-158 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 51407-003 | Ondansetron Hydrochloride 4 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-004 | Ondansetron Hydrochloride 8 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 85534-0025 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | HAWAII REPACK, INC. | ANDA |
| 85534-0063 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | HAWAII REPACK, INC. | ANDA |
| 0404-9930 | Ondansetron Hydrochloride 2 mg/mL Injection | Henry Schein, Inc. | ANDA |
| 23155-547 | Ondansetron Hydrochloride 2 mg/mL Injection | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-549 | Ondansetron Hydrochloride 2 mg/mL Injection | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-550 | Ondansetron Hydrochloride 2 mg/mL Injection | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-548 | Ondansetron Hydrochloride 2 mg/mL Injection | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 51662-1245 | Ondansetron Hydrochloride 2 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1246 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1366 | Ondansetron Hydrochloride 2 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1678 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1539 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1514 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1469 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1377 | Ondansetron Hydrochloride 2 mg/mL Injection | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 0641-6078 | Ondansetron Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0641-6079 | Ondansetron Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0641-6080 | Ondansetron Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0641-6286 | Ondansetron Hydrochloride 2 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0409-2271 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-4755 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-4759 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-0009 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 83980-012 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Ipca Laboratories Limited | ANDA |
| 83980-013 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Ipca Laboratories Limited | ANDA |
| 86211-115 | Ondansetron Hydrochloride 2 mg/mL Injection | JVET PHARMACEUTICALS LLC | ANDA |
| 72336-073 | Ondansetron 16 mg/1 Tablet, Orally Disintegrating | Lifsa Drugs LLC | ANDA |
| 0904-6552 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-6551 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 71872-7162 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7068 | Ondansetron Hydrochloride 2 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7107 | Ondansetron Hydrochloride 2 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7140 | Ondansetron Hydrochloride 2 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 63850-0004 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Natco Pharma Limited | ANDA |
| 63850-0003 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Natco Pharma Limited | ANDA |
| 69339-171 | Ondansetron Hydrochloride 4 mg/1 Tablet | Natco Pharma USA LLC | ANDA |
| 69339-172 | Ondansetron Hydrochloride 8 mg/1 Tablet | Natco Pharma USA LLC | ANDA |
| 16714-159 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-160 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | NorthStar Rx LLC | ANDA |
| 16714-200 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NorthStar Rx LLC | ANDA |
| 16714-201 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NorthStar Rx LLC | ANDA |
| 16714-671 | Ondansetron Hydrochloride 4 mg/5mL Solution | NorthStar Rx LLC | ANDA |
| 51655-196 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Northwind Health Company, LLC | ANDA |
| 51655-008 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Northwind Health Company, LLC | ANDA |
| 51655-809 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Northwind Health Company, LLC | ANDA |
| 51655-913 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Northwind Health Company, LLC | ANDA |
| 68071-3801 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3713 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3268 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3926 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc | ANDA |
| 68071-4570 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1730 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2284 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2718 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2763 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2901 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3611 | Ondansetron Hydrochloride 4 mg/5mL Solution | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5230 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5167 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5021 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4881 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4834 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4115 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | NuCare Pharmaceuticals,Inc. | ANDA |
| 0121-4882 | Ondansetron Hydrochloride 4 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 0121-0882 | Ondansetron Hydrochloride 4 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA |
| 43063-273 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-770 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-857 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-870 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 54348-819 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | PharmPak, Inc. | ANDA |
| 68788-8666 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4133 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7565 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-7644 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-9559 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Preferred Pharmaceuticals, Inc. | ANDA |
| 63187-199 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 63187-065 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-236 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-256 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 63187-266 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 63187-379 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 63187-513 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-670 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 63187-693 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 71205-713 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 63187-526 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Proficient Rx LP | ANDA |
| 84549-130 | Ondansetron Hydrochloride 2 mg/mL Injection | ProPharma Distribution | ANDA |
| 67184-0507 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Qilu Pharmaceutical Co., Ltd. | ANDA |
| 67296-2119 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 70518-4685 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | REMEDYREPACK INC. | ANDA |
| 70518-4245 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4588 | Ondansetron Hydrochloride 4 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-1551 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | REMEDYREPACK INC. | ANDA |
| 70518-3512 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | REMEDYREPACK INC. | ANDA |
| 57237-078 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Rising Pharma Holdings, Inc. | ANDA |
| 57237-077 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Rising Pharma Holdings, Inc. | ANDA |
| 25021-777 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 85766-038 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Sportpharm LLC | ANDA |
| 85766-199 | Ondansetron Hydrochloride 2 mg/mL Injection, Solution | Sportpharm LLC | ANDA |
| 85766-213 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Sportpharm LLC | ANDA |
| 85766-234 | Ondansetron Hydrochloride 2 mg/mL Injection | Sportpharm LLC | ANDA |
| 60760-306 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-654 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-936 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | St. Mary's Medical Park Pharmacy | ANDA |
| 63304-459 | Ondansetron Hydrochloride 8 mg/1 Tablet, Film Coated | Sun Pharmaceutical Industries, Inc. | ANDA |
| 62756-356 | Ondansetron 8 mg/1 Tablet, Orally Disintegrating | Sun Pharmaceutical Industries, Inc. | ANDA |
| 63304-458 | Ondansetron Hydrochloride 4 mg/1 Tablet, Film Coated | Sun Pharmaceutical Industries, Inc. | ANDA |
| 62756-240 | Ondansetron 4 mg/1 Tablet, Orally Disintegrating | Sun Pharmaceutical Industries, Inc. | ANDA |
| 0143-9891 | Ondansetron Hydrochloride 2 mg/mL Injection | West-Ward Pharmaceuticals Corp | ANDA |
| 0143-9890 | Ondansetron Hydrochloride 2 mg/mL Injection | West-Ward Pharmaceuticals Corp | ANDA |
Ondansetron recalls
- D-0246-2026 Jan 7, 2026 · Class II · Ongoing
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… - D-1386-2019 Jun 19, 2019 · Class III · Terminated
Failed Impurities/Degradation Specifications. - D-0296-2015 Dec 17, 2014 · Class II · Terminated
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. - D-013-2014 Nov 27, 2013 · Class II · Terminated
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. - D-851-2013 Aug 14, 2013 · Class II · Terminated
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Frequently asked questions
What is Ondansetron used for?
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the…
What are the side effects of Ondansetron?
The following have been reported as adverse events in clinical trials of patients treated with ondansetron, the active ingredient of ondansetron tablets. A causal relationship to therapy with ondansetron tablets have been unclear in many cases. Chemotherapy-Induced Nausea and Vomiting The adverse events in Table 5 have been reported in ≥ 5% of adult patients receiving a single 24 mg ondansetron… See the full label for the complete list.
Who makes Ondansetron?
Ondansetron is listed by 62 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare, Inc., Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC.
Has Ondansetron been recalled?
The FDA enforcement database lists 5 recalls for Ondansetron, most recently D-0246-2026 (class ii): Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets…