Home › NDC Lookup › Ingredients › Ondansetron › 00409-0009-25
💉image loading
(from DailyMed)

Ondansetron 2 mg/mL Injection, Solution — NDC 0409-0009-25 (Billing 00409-0009-25)

by Hospira, Inc. · 25 VIAL, SINGLE-DOSE in 1 TRAY / 2 mL in 1 VIAL, SINGLE-DOSE

This is a package of Ondansetron 2 mg/mL Injection, Solution from Hospira, Inc., marketed since Dec 2024 and currently FDA-listed; retail pharmacies pay about $0.1759 per mL (NADAC). It is this product's only package size.

NDC 00409-0009-25
🏷️ FDA NDC (as labeled) 0409-0009-25 billing pads the labeler 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

NDC database record

One package, one record: these facts belong to NDC 0409-0009-25 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0409 labeler · 0009 product · 25 package
Package marketed since
Dec 16, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0409000925 8
Medicaid fills, this package
31,826 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
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) 0409-0009-25
Product NDC 0409-0009
11-digit billing NDC 00409000925
NCPDP billing unit ML — per mL (volume)
RxCUI 1740467
UNII NMH84OZK2B
Application # ANDA077548
SPL Set ID d62cd60b-f87e-4825-bead-1d18bbc4e480
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 2024-12-16
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ONDANSETRON HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 50250065052024
GCN Seq No 061716
GCN 97502
HICL code 033598
Ingredient (HICL) Ondansetron Hcl/Pf
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 56:22.20.00
AHFS class 5-Ht3 Receptor Antagonists
FDB label name ONDANSETRON HCL 4 MG/2 ML VIAL
FDB brand name Ondansetron Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 061716
  • GCN: 97502
  • GPI-14 (Medi-Span): 50250065052024
  • HICL (First Databank): 033598
  • AHFS class code: 56:22.20.00
  • RxCUI (RxNorm): 1740467
Why two NDCs? The FDA registers this code as 0409-0009-25 — a 4-4-2 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 labeler segment → 00409-0009-25. 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

Label name ONDANSETRON HCL 4 MG/2 ML VIAL Ingredient Ondansetron Hcl/Pf
📗 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 mLPer package
Retail pharmacies payNADAC · weekly $0.176 $8.80 / 50 ml
Medicaid paysCMS SDUD · 12 mo $5.35 $267.50 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2405 $0.088 / J2405 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.198 $0.176
▼ Down 11% over the last 10 months.
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.

Billing & reimbursement

FDA NDC (as labeled)0409-0009-25
11-digit billing NDC00409-0009-25
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2405
DescriptorINJECTION, ONDANSETRON HYDROCHLORIDE, PER 1 MG
Billing units / pkg2 units
How the units are derivedThis package is 2 ML; the HCPCS unit is 1 MG, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$35,446 · 43,411 claims · $0.82 per claim (all NDCs under J2405)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00409-0009-25 You're viewing this Main listing 25 VIAL, SINGLE-DOSE in 1 TRAY / 2 mL in 1 VIAL, SINGLE-DOSE 2024-12-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ondansetron 2 mg/mL 23155-0550-31 Heritage 1 vial $0.173 AP Availability likely save 2%
Ondansetron 2 mg/mL 00641-6286-01 Hikma 20 ml $0.173 AP Availability likely save 2%
Ondansetron 2 mg/mL 00641-6079-01 Hikma 20 ml $0.173 AP Availability likely save 2%
Ondansetron 2 mg/mL 00409-4759-01 Hospira, 1 vial $0.173 AP Availability likely save 2%
Ondansetron 2 mg/mL 23155-0549-31 Heritage 1 vial $0.173 AP Availability likely save 2%
Ondansetron 2 mg/mL 72266-0124-01 Fosun 1 vial $0.173 AP Availability likely save 2%
Ondansetron 2 mg/mLthis 00409-0009-25 Hospira, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00409-2271-25 Hospira, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00409-4755-03 Hospira, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00641-6078-25 Hikma 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 00641-6080-25 Hikma 25 vials $0.176 AP Availability likely —
ondansetron 2 mg/mL 25021-0777-02 Sagent 25 vials $0.176 AP Availability likely —
Ondansetron Hydrochloride 2 mg/mL 36000-0012-25 Baxter 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 60505-6130-05 Apotex 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 63323-0373-02 Fresenius 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 65219-0323-02 Fresenius 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 72266-0123-25 Fosun 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 72572-0520-25 Civica, 25 vials $0.176 AP Availability likely —
Ondansetron 2 mg/mL 55150-0125-02 Eugia 25 vials $0.197 — FDA listed +12%
Ondansetron 2 mg/mL 00143-9891-25 West-Ward 25 vials — — FDA listed —
Ondansetron 2 mg/mL 00404-9930-02 Henry 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 23155-0547-41 Heritage 10 vials — AP FDA listed —
Ondansetron 2 mg/mL 23155-0548-41 Heritage 10 vials — AP FDA listed —
Ondansetron 2 mg/mL 50090-4935-00 A-S 25 vials — AP FDA listed —
Ondansetron 2 mg/mL 51662-1245-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 51662-1366-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 51662-1469-01 HF 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 55154-2876-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 55154-2877-05 Cardinal 5 vials — AP FDA listed —
Ondansetron Hydrochloride 2 mg/mL 55154-4453-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 55154-6976-05 Cardinal 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 67184-0507-05 Qilu 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 68083-0113-01 Gland 5 vials — AP FDA listed —
Ondansetron 2 mg/mL 71872-7068-01 Medical 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 71872-7140-01 Medical 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 71872-7162-01 Medical 1 vial — AP FDA listed —
ondansetron hydrochloride 2 mg/mL 83270-0160-03 Onesource 25 vials — — FDA listed —
Ondansetron 2 mg/mL 84549-0130-05 ProPharma 2 ml — AP FDA listed —
Ondansetron 2 mg/mL 00143-9890-01 West-Ward 20 ml — — FDA listed —
Ondansetron 2 mg/mL 71872-7107-01 Medical 1 vial — — FDA listed —
Ondansetron 2 mg/mL 85766-0199-20 Sportpharm 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 86211-0115-01 JVET 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 51662-1377-01 HF 20 ml — AP FDA listed —
Ondansetron 2 mg/mL 68083-0114-01 Gland 1 vial — AP FDA listed —
Ondansetron 2 mg/mL 85766-0234-25 Sportpharm 25 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerHospira, Inc.
Application holderHOSPIRA INC
FDA applicationANDA077548 (ANDA)
Labeler code00409
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio317 products on file

More NDCs from Hospira, Inc. labeler code 00409

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 195 words ▾

1 INDICATIONS AND USAGE Ondansetron Injection is a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. ( 1.1 ) • postoperative nausea and/or vomiting. ( 1.2 )

1.1Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron is approved for patients aged 6 months and older.

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

For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes. Ondansetron is approved for patients aged 1 month and older.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy ( 2.1 ): • Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients. • Adults and pediatric patients 6 months of age and older: The recommended dosage is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose), infused intravenously over 15 minutes. • Administer the first dose 30 minutes before the start of chemotherapy and subsequent doses 4 and 8 hours after the first dose.

Prevention of Postoperative Nausea and/or Vomiting ( 2.2 ): • Dilution of Ondansetron Injection is not required before administration to adult and pediatric patients. • See full prescribing information for the recommended dosage and administration instructions for adult and pediatric patients 1 month of age and older. Patients With Severe Hepatic Impairment ( 2.3 ): • Do not exceed a total daily dose of 8 mg.

2.1Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Chemotherapy Important Preparation Instructions • Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. For pediatric patients between 6 months and 1 year of age and/or 10 kg or less: Depending on the fluid needs of the patient, Ondansetron Injection may be diluted in 10 to 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection. • Occasionally, ondansetron precipitates at the stopper/vial interface in vials stored upright.

Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously. • Do not mix Ondansetron Injection with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form. • Inspect the diluted Ondansetron Injection solution for particulate matter and discoloration before administration; discard if present. • Storage : After dilution, do not use beyond 24 hours.

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

Dosage and Administration The recommended dosage for adult and pediatric patients 6 months of age and older for prevention of nausea and vomiting associated with emetogenic chemotherapy is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose). Caution : Dilution of Ondansetron Injection is required in adult and pediatric patients prior to administration. Infuse intravenously over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy and then repeat 4 and 8 hours after the first dose.

2.2Prevention of Postoperative Nausea and/or Vomiting Important Preparation Instructions • Dilution of Ondansetron Injection is not required before administration to adult and pediatric patients. • Inspect Ondansetron Injection visually for particulate matter and discoloration before administration; discard if present. Dosage and Administration The recommended dose and administration instructions for adult and pediatric patients 1 month of age and older for prevention of postoperative nausea and vomiting are shown in Table 1.

Table 1. Recommended Dose and Administration of Ondansetron Injection for Prevention of Postoperative Nausea… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Ondansetron Injection USP: 2 mg/mL clear, colorless, nonpyrogenic, sterile solution in a 2 mL single-dose vial. Ondansetron Injection (2 mg/mL): 2 mL single-dose vial. ( 3 )

⛔ Contraindications 91 words ▾

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

( 4 ) • Concomitant use of apomorphine. ( 4 , 7.2 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Hypersensitivity reactions, including anaphylaxis and bronchospasm have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists. ( 5.1 ) • QT Prolongation and Torsade de Pointes : QT prolongation occurs in a dose-dependent manner. Cases of Torsade de Pointes have been reported.

Avoid ondansetron in patients with congenital long QT syndrome. ( 5.2 ) • Serotonin Syndrome : Serotonin syndrome has been reported with 5-HT 3 receptor agonists alone but particularly with concomitant use of serotonergic drugs. ( 5.3 ) • Myocardial Ischemia : Do not exceed the recommended infusion rate and monitor patients during and after administration.

( 2.1 , 2.2 , 5.4 ) • Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. ( 5.5 )

5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT 3 receptor antagonists.

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

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

5.3Serotonin Syndrome The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal.

Serotonin syndrome occurring with overdose of ondansetron alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT 3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

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

5.4Myocardial Ischemia Myocardial ischemia has been reported in patients treated with ondansetron. In some cases, predominantly during intravenous administration, the symptoms appeared immediately after administration but resolved with prompt treatment. Coronary artery spasm appears to be the most common underlying cause.

Therefore, do not exceed the recommended infusion rate of ondansetron and monitor patients for signs and symptoms of myocardial ischemia during and after administration [see Dosage and Administration (2.1 , 2.2) and Adverse Reactions (6.2) ] .

5.5Masking of Progressive Ileus and Gastri… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • QT Prolongation [see Warnings and Precautions (5.2) ] • Serotonin Syndrome [see Warnings and Precautions (5.3) ] • Myocardial Ischemia [see Warnings and Precautions (5.4) ] • Masking of Progressive Ileus and Gastric Distension [see Warnings and Precautions (5.5) ] Chemotherapy-Induced Nausea and Vomiting: • The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever.

( 6.1 ) Postoperative Nausea and/or Vomiting: • The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared with placebo in adults is headache. ( 6.1 ) • The most common adverse reaction (≥ 2%) which occurs at a higher frequency compared with placebo in pediatric patients aged 1 to 24 months is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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 clinical practice. The following adverse reactions have been reported in clinical trials of adult patients treated with ondansetron, the active ingredient of intravenous ondansetron across a range of dosages. A causal relationship to therapy with ondansetron was unclear in many cases.

Chemotherapy-Induced Nausea and Vomiting Table 2. Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15 mg/kg Doses Number of Adult Patients With Reaction Adverse Reaction Ondansetron Injection 0.15 mg/kg × 3 (n = 419) Metoclopramide (n = 156) Placebo (n = 34) Diarrhea 16% 44% 18% Headache 17% 7% 15% Fever 8% 5% 3% Cardiovascular : Rare cases of angina (chest pain), electrocardiographic alterations, hypotension, and tachycardia have been reported. Gastrointestinal : Constipation has been reported in 11% of chemotherapy patients receiving multiday ondansetron.

Hepatic : In comparative trials in cisplatin chemotherapy patients with normal baseline values of aspartate transaminase (AST) and alanine transaminase (ALT), these enzymes have been reported to exceed twice the upper limit of normal in approximately 5% of patients. The increases were transient and did not appear to be related to dose or duration of therapy. On repeat exposure, similar transient elevations in transaminase values occurred in some courses, but symptomatic hepatic disease did not occur.

Integumentary : Rash has occurred in approximately 1% of patients receiving ondansetron. Neurological : There have been rare reports consistent with, but not diagnostic of, extrapyramidal reactions in patients receiving Ondansetron Injection, and rare cases of grand mal seizure. Other : Rare cases of hypokalemia have been reported.

Postoperative Nausea and/or Vomiting The adverse reactions in Table 3 have been reported in ≥ 2% of adults receiving ondansetron at a dosage of 4 mg intravenous over 2 to 5 minutes in clinical trials. Table 3. Adverse Reactions Reported in ≥ 2% (and with greater frequency than the placebo group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous Over 2 to 5 Minutes Adverse Reaction Adverse reactions: Rates of these reactions were not significantly different in the ondansetron and placebo groups. , Patients were receiving multiple concomitant perioperative and postoperative medications.

Ondansetron Injection 4 mg Intravenous (n = 547) Placebo (n = 547) Headache 92 (17%) 77 (14%) Drowsiness/Sedation 44 (8%) 37 (7%) Injection-site reaction 21 (4%) 18 (3%) Fever 10 (2%) 6 (1%) Cold sensation 9 (2%) 8 (1%) Pruritus 9 (2%) 3 (< 1%) Paresthesia 9 (2%) 2 (< 1%) Pediatric Use : Rates of adverse reac… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

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

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

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

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

7.5Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including SSRIs and SNRIs [see Warnings and Precautions (5.3) ] .

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

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

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

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see Data ) . Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (BSA), respectively (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. 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 Available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses.

One large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. Two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. Relative risks (RR) ranged from 0.97 (95% CI 0.86 to 1.10) to 1.62 (95% CI 1.04, 2.54).

A subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (RR 2.05, 95% CI 1.19, 3.28); however this association was not confirmed in other studies. Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. A retrospective cohort study of 1.8 million pregnancies in the US Medicaid Database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (RR 1.24, 95% CI 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (RR 0.95, 95% CI 0.63, 1.43).

In the subgroup of women who received both forms of administration, the RR was 1.07 (95% CI 0.59, 1.93). Two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (OR 1.6 [95% CI 1.1, 2.3] and 0.5 [95% CI 0.3, 1.0]). 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).

Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. With the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. A… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see Data ) . Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (BSA), respectively (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. 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 Available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses.

One large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. Two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. Relative risks (RR) ranged from 0.97 (95% CI 0.86 to 1.10) to 1.62 (95% CI 1.04, 2.54).

A subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (RR 2.05, 95% CI 1.19, 3.28); however this association was not confirmed in other studies. Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. A retrospective cohort study of 1.8 million pregnancies in the US Medicaid Database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (RR 1.24, 95% CI 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (RR 0.95, 95% CI 0.63, 1.43).

In the subgroup of women who received both forms of administration, the RR was 1.07 (95% CI 0.59, 1.93). Two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (OR 1.6 [95% CI 1.1, 2.3] and 0.5 [95% CI 0.3, 1.0]). 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).

Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. With the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. At doses of 10 mg/kg/day in rat… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 109 words ▾

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

As a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see Clinical Pharmacology (12.3) ] .

🧓 Geriatric Use 142 words ▾

8.5Geriatric Use Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting US- and foreign-controlled clinical trials, 862 were aged 65 years and older. No overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology (12.3) ] .

There were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. 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.

🆘 Overdosage 205 words ▾

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

These doses are more than 10 times the recommended daily dose. In addition to the adverse reactions listed above, the following events have been described in the setting of ondansetron overdose: "Sudden blindness" (amaurosis) of 2 to 3 minutes' duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single-dose. Hypotension (and faintness) occurred in another patient that took 48 mg of ondansetron hydrochloride 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. Pediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeding estimated ingestion of 5 mg/kg) in young children.

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ondansetron is a selective 5-HT 3 receptor antagonist. While ondansetron's mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

12.2Pharmacodynamics In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. In another trial in 6 normal male volunteers, a 16 mg dose infused over 5 minutes showed no effect of the drug on cardiac output, heart rate, stroke volume, blood pressure, or ECG. Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers.

Ondansetron has no effect on plasma prolactin concentrations. In a gender balanced pharmacodynamic trial (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis. Cardiac Electrophysiology QTc interval prolongation was studied in a double-blind, single intravenous dose, placebo- and positive-controlled, crossover trial in 58 healthy subjects.

The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 19.5 (21.8) ms and 5.6 (7.4) ms after 15-minute intravenous infusions of 32 mg and 8 mg Ondansetron Injection, respectively. A significant exposure-response relationship was identified between ondansetron concentration and ΔΔQTcF. Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) ΔΔQTcF of 14.0 (16.3) ms.

In contrast, 16 mg infused intravenously over 15 minutes using the same model had a mean predicted (95% upper prediction interval) ΔΔQTcF of 9.1 (11.2) ms. In this study, the 8 mg dose infused over 15 minutes did not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics In normal adult volunteers, the following mean pharmacokinetic data have been determined following a single 0.15 mg/kg intravenous dose. Table 4. Pharmacokinetics in Normal Adult Volunteers Age-group (years) n Peak Plasma Concentration (ng/mL) Mean Elimination Half-life (h) Plasma Clearance (L/h/kg) 19–40 11 102 3.5 0.381 61–74 12 106 4.7 0.319 ≥ 75 11 170 5.5 0.262 Absorption A trial was performed in normal volunteers (n = 56) to evaluate the pharmacokinetics of a single 4 mg dose administered as a 5-minute infusion compared with a single intramuscular injection.

Systemic exposure as measured by mean area under curve (AUC) were equivalent, with values of 156 [95% CI 136, 180] and 161 [95% CI 137, 190] ng∙h/mL for intravenous and intramuscular groups, respectively. Mean peak plasma concentrations were 42.9 [95% CI 33.8, 54.4] ng/mL at 10 minutes after intravenous infusion and 31.9 [95% CI 26.3, 38.6] ng/mL at 41 minutes after intramuscular injection. Distribution Plasma protein binding of ondansetron as measured in vitro was 70% to 76%, over the pharmacologic concentration range of 10 to 500 ng/mL.

Circulating drug also distributes into erythrocytes. Elimination Metabolism : Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.

Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. The metabolites are observed in the urine. In vitro metabolism studies have shown that ondansetron is a substrate for multiple human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4.

In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is appare… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 28 words ▾

12.1Mechanism of Action Ondansetron is a selective 5-HT 3 receptor antagonist. While ondansetron's mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ondansetron Injection, USP, 2 mg/mL, is supplied as follows: Unit of Sale Concentration NDC 0409-0009-25 Tray of 25 2 mL Single-dose Vials 4 mg/2 mL (2 mg/mL) Storage: Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Product may also be stored in a refrigerator, 2°C to 8°C (36°F to 46°F). Retain in carton until time of use. Protect from light.

📦 Storage and Handling 38 words ▾

Storage: Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Product may also be stored in a refrigerator, 2°C to 8°C (36°F to 46°F). Retain in carton until time of use. Protect from light.

📋 Description 153 words ▾

11 DESCRIPTION The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT 3 receptor type. Its chemical name 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 g/mol.

Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2-mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of sodium chloride, USP; and 0.46 mg of citric acid anhydrous, USP and 0.25 mg of sodium citrate dihydrate, USP as buffers in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use.

The pH of the injection solution is 3.3 to 4.0. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Inform patients that Ondansetron Injection may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. The patient should report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems [see Warnings and Precautions (5.1) ] QT Prolongation Patients should be informed that Ondansetron Injection may cause serious cardiac arrhythmias, such as QT prolongation. Patients should be instructed to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.

Patients should be informed that the chances of developing severe cardiac arrhythmias, such as QT prolongation and Torsade de Pointes are higher in the following people: • Patients with a personal or family history of abnormal heart rhythms, such as congenital long QT syndrome; • Patients who take medications, such as diuretics, which may cause electrolyte abnormalities; • Patients with hypokalemia or hypomagnesemia. Ondansetron Injection should be avoided in these patients, since they may be more at risk for cardiac arrhythmias, such as QT prolongation and Torsade de Pointes [see Warnings and Precautions (5.2) ] .

Drug Interactions • Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and Ondansetron Injection may cause a significant drop in blood pressure and loss of consciousness. • Advise patients of the possibility of serotonin syndrome with concomitant use of Ondansetron Injection and another serotonergic agent, such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.3) ] .

Myocardial Ischemia Inform patients that Ondansetron Injection may cause myocardial ischemia during or after the administration. Advise patients to seek immediate medical help if any symptoms suggestive of a myocardial ischemia occur, such as sudden chest pain or chest tightness [see Warnings and Precautions (5.4) ] . Masking of Progressive Ileus and Gastric Distension Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that Ondansetron Injection may mask signs and symptoms of bowel obstruction.

Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider [see Warnings and Precautions (5.5) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics In normal adult volunteers, the following mean pharmacokinetic data have been determined following a single 0.15 mg/kg intravenous dose. Table 4. Pharmacokinetics in Normal Adult Volunteers Age-group (years) n Peak Plasma Concentration (ng/mL) Mean Elimination Half-life (h) Plasma Clearance (L/h/kg) 19–40 11 102 3.5 0.381 61–74 12 106 4.7 0.319 ≥ 75 11 170 5.5 0.262 Absorption A trial was performed in normal volunteers (n = 56) to evaluate the pharmacokinetics of a single 4 mg dose administered as a 5-minute infusion compared with a single intramuscular injection.

Systemic exposure as measured by mean area under curve (AUC) were equivalent, with values of 156 [95% CI 136, 180] and 161 [95% CI 137, 190] ng∙h/mL for intravenous and intramuscular groups, respectively. Mean peak plasma concentrations were 42.9 [95% CI 33.8, 54.4] ng/mL at 10 minutes after intravenous infusion and 31.9 [95% CI 26.3, 38.6] ng/mL at 41 minutes after intramuscular injection. Distribution Plasma protein binding of ondansetron as measured in vitro was 70% to 76%, over the pharmacologic concentration range of 10 to 500 ng/mL.

Circulating drug also distributes into erythrocytes. Elimination Metabolism : Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation.

Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. The metabolites are observed in the urine. In vitro metabolism studies have shown that ondansetron is a substrate for multiple human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4.

In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is apparently mediated by CYP1A2. The role of CYP2D6 in ondansetron in vivo metabolism is relatively minor. The pharmacokinetics of intravenous ondansetron did not differ between subjects who were poor metabolizers of CYP2D6 and those who were extensive metabolizers of CYP2D6, further supporting the limited role of CYP2D6 in ondansetron disposition in vivo .

Excretion : In adult cancer patients, the mean ondansetron elimination half-life was 4.0 hours, and there was no difference in the multidose pharmacokinetics over a 4-day period. In a dose-proportionality trial, systemic exposure to 32 mg of ondansetron was not proportional to dose as measured by comparing dose-normalized AUC values with an 8 mg dose. This is consistent with a small decrease in systemic clearance with increasing plasma concentrations.

Specific Populations Geriatric Patients : A reduction in clearance and increase in elimination half-life are seen in patients older than 75 years of age [see Use in Specific Populations (8.5) ] . Pediatric Patients : Pharmacokinetic samples were collected from 74 cancer patients aged 6 to 48 months, who received a dose of 0.15 mg/kg of intravenous ondansetron every 4 hours for 3 doses during a safety and efficacy trial. These data were combined with sequential pharmacokinetics data from 41 surgery patients aged 1 month to 24 months, who received a single-dose of 0.1 mg/kg of intravenous ondansetron prior to surgery with general anesthesia, and a population pharmacokinetic analysis was performed on the combined data set.

The results of this analysis are included in Table 5 and are compared with the pharmacokinetic results in cancer patients aged 4 to 18 years. Table 5. Pharmacokinetics in Pediatric Cancer Patients Aged 1 Month to 18 Years Subjects and Age-group N CL (L/h/kg) Vd ss (L/kg) t ½ (h) Geometric Mean Mean Pediatric Cancer Patients 4 to 18 years N = 21 0.599 1.9

2.8Population PK Patients Population PK (Pharmacokinetic) Patients: 64% cancer patients… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics In normal volunteers, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. In another trial in 6 normal male volunteers, a 16 mg dose infused over 5 minutes showed no effect of the drug on cardiac output, heart rate, stroke volume, blood pressure, or ECG. Multiday administration of ondansetron has been shown to slow colonic transit in normal volunteers.

Ondansetron has no effect on plasma prolactin concentrations. In a gender balanced pharmacodynamic trial (n = 56), ondansetron 4 mg administered intravenously or intramuscularly was dynamically similar in the prevention of nausea and vomiting using the ipecacuanha model of emesis. Cardiac Electrophysiology QTc interval prolongation was studied in a double-blind, single intravenous dose, placebo- and positive-controlled, crossover trial in 58 healthy subjects.

The maximum mean (95% upper confidence bound) difference in QTcF from placebo after baseline correction was 19.5 (21.8) ms and 5.6 (7.4) ms after 15-minute intravenous infusions of 32 mg and 8 mg Ondansetron Injection, respectively. A significant exposure-response relationship was identified between ondansetron concentration and ΔΔQTcF. Using the established exposure-response relationship, 24 mg infused intravenously over 15 minutes had a mean predicted (95% upper prediction interval) ΔΔQTcF of 14.0 (16.3) ms.

In contrast, 16 mg infused intravenously over 15 minutes using the same model had a mean predicted (95% upper prediction interval) ΔΔQTcF of 9.1 (11.2) ms. In this study, the 8 mg dose infused over 15 minutes did not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

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

14.1Chemotherapy-Induced Nausea and Vomiting Adults In a double-blind trial of three different dosing regimens of Ondansetron Injection, 0.015 mg/kg, 0.15 mg/kg, and 0.30 mg/kg, each given three times during the course of cancer chemotherapy, the 0.15 mg/kg dosing regimen was more effective than the 0.015 mg/kg dosing regimen. The 0.30 mg/kg dosing regimen was not shown to be more effective than the 0.15 mg/kg dosing regimen. Cisplatin-Based Chemotherapy : In a double-blind trial in 28 patients, Ondansetron Injection (three 0.15 mg/kg doses) was significantly more effective than placebo in preventing nausea and vomiting induced by cisplatin-based chemotherapy.

Therapeutic response was as shown in Table 7. Table 7. Therapeutic Response in Prevention of Chemotherapy-Induced Nausea and Vomiting in Single-day Cisplatin Therapy Chemotherapy was high dose (100 and 120 mg/m 2 ; Ondansetron Injection n = 6, placebo n = 5) or moderate dose (50 and 80 mg/m 2 ; Ondansetron Injection n = 8, placebo n = 9).

Other chemotherapeutic agents included fluorouracil, doxorubicin, and cyclophosphamide. There was no difference between treatments in the types of chemotherapy that would account for differences in response. in Adults Ondansetron Injection (0.15 mg/kg × 3) Placebo P-v alue Efficacy based on "all-patients-treated" analysis. Number of patients 14 14 Treatment response 0 Emetic episodes 2 (14%) 0 (0%) 1–2 Emetic episodes 8 (57%) 0 (0%) 3–5 Emetic episodes 2 (14%) 1 (7%) More than 5 emetic episodes/rescued 2 (14%) 13 (93%) 0.001 Median number of emetic episodes

1.5Undefined Median undefined since at least 50% of the patients were rescued or had more than five emetic episodes. Median time to first emetic episode (h) 11.6 2.8 0.001 Median nausea scores (0–100) Visual analog scale assessment of nausea: 0 = no nausea, 100 = nausea as bad as it can be. 3 59 0.034 Global satisfaction with control of nausea and vomiting (0–100) Visual analog scale assessment of satisfaction: 0 = not at all satisfied, 100 = totally satisfied.

96 10.5 0.009 Ondansetron injection (0.15 mg/kg × 3 doses) was compared with metoclopramide (2 mg/kg × 6 doses) in a single-blind trial in 307 patients receiving cisplatin ≥ 100 mg/m 2 with or without other chemotherapeutic agents. Patients received the first dose of ondansetron or metoclopramide 30 minutes before cisplatin. Two additional ondansetron doses were administered 4 and 8 hours later, or five additional metoclopramide doses were administered 2, 4, 7, 10, and 13 hours later.

Cisplatin was administered over a period of 3 hours or less. Episodes of vomiting and retching were tabulated over the period of 24 hours after cisplatin. The results of this trial are summarized in Table 8.

Table 8. Therapeutic Response in Prevention of Vomiting Induced by Cisplatin (≥ 100 mg/m 2 ) Single-day Therapy In addition to cisplatin, 68% of patients received other chemotherapeutic agents, including cyclophosphamide, etoposide, and fluorouracil. There was no difference between treatments in the types of chemotherapy that would account for differences in response. in Adults Ondansetron Injection 0.15 mg/kg × 3 Metoclopramide 2 mg/kg × 6 P-v alue Number of patients in efficacy population 136 138 Treatment response 0 Emetic episodes 54 (40%) 41 (30%) 1–2 Emetic episodes 34 (25%) 30 (22%) 3–5 Emetic episodes 19 (14%) 18 (13%) More than 5 emetic episodes/rescued 29 (21%) 49 (36%) Comparison of treatments with respect to 0 Emetic episodes 54/136 41/138 0.083 More than 5 emetic episodes/rescued 29/136 49/138 0.009 Median number of emetic episodes 1 2 0.005 Median time to first emetic episode (h) 20.5 4.3 < 0.001 Global satisfaction with control of nausea and vomiting (0–100) Visual analog scale assessment: 0 = not at all satisfied, 100 = totally satisfied.

85 63 0.001 Acute dystonic… [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 98 words ▾

13 NONCLINICAL TOXICOLOGY

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

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 95 words ▾

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

📄 Package Label / Principal Display Panel 81 words ▾

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label 2 mL Single-dose Vial NDC 0409-0009-02 Rx only Ondansetron Injection, USP 4 mg/2 mL (2 mg/mL) PROTECT FROM LIGHT Dist. by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton 25 x 2 mL Single-dose Sterile Fliptop Vials NDC 0409-0009-25 Rx only Ondansetron Injection, USP 4 mg/2 mL (2 mg/mL) PAA226421 PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
31.8K
Units reimbursed last 4 qtrs
72.7K
Gross reimbursed last 4 qtrs
$388.8K
Avg / prescription
$12.22
Avg / unit
$5.3500
Latest quarter Q1 2026
11.4KRx
Medicaid pays / mL
$5.3500
gross reimbursed
vs
NADAC / mL
$0.1759
acquisition cost
=
Spread
+$5.1741
+2942% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
91% MCO
Fee-for-service · 2,948 Rx Managed care · 28,878 Rx
State Medicaid map
Alaska: no data reported AK Maine: 21 units · 1.5 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 358 units · 31.6 per 100k residents MT North Dakota: 24 units · 3.1 per 100k residents ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 138 units · 0.7 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,271 units · 90.7 per 100k residents NH Oregon: no data reported OR Nevada: 17,364 units · 544 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 604 units · 18.8 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 7,843 units · 66.6 per 100k residents OH Pennsylvania: 4,256 units · 32.8 per 100k residents PA New Jersey: 675 units · 7.3 per 100k residents NJ Massachusetts: 630 units · 9.0 per 100k residents MA California: 8,995 units · 23.1 per 100k residents CA Utah: no data reported UT Colorado: 74 units · 1.3 per 100k residents CO Nebraska: 282 units · 14.3 per 100k residents NE Missouri: 90 units · 1.5 per 100k residents MO Kentucky: 455 units · 10.1 per 100k residents KY West Virginia: no data reported WV Virginia: 436 units · 5.0 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 294 units · 4.0 per 100k residents AZ New Mexico: no data reported NM Kansas: 1,212 units · 41.2 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,850 units · 17.1 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 833 units · 20.6 per 100k residents OK Louisiana: 199 units · 4.4 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,272 units · 11.5 per 100k residents GA D.C.: 1,116 units · 164 per 100k residents DC Hawaii: no data reported HI Texas: 9,138 units · 30.0 per 100k residents TX Florida: 13,251 units · 58.6 per 100k residents FL
Units reimbursed · per 100k residents
0.7544
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 544 /100k
2 D.C. 164 /100k
3 New Hampshire 90.7 /100k
4 Ohio 66.6 /100k
5 Florida 58.6 /100k
6 Kansas 41.2 /100k
7 Pennsylvania 32.8 /100k
8 Montana 31.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
← 00409-0007-10 · Hospira, 00409-0010-98 · Hospira, →
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.