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Ondansetron Injection: Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
4 mg/2 mL
Active ingredient:

Patient information: uses, side effects, how to take - Ondansetron Injection

INSTRUCTIONS FOR USE

Figure 1: Outer Packaging and Prefilled Syringe

NOTES:

  • Do not introduce any other fluid into the syringe at any time.
  • Do not dilute for IV push.
  • Do not re-sterilize the syringe.
  • Do not use this product on a sterile field.
  • This product is for single dose only.
  1. 1. Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged.
  2. 2.

    Remove the syringe from the outer packaging. (See Figure 2)

    Figure 2

  3. 3. Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  4. 4.

    Twist off the syringe tip cap. Do not remove the label around the luer lock collar. (See Figure 3)

    Figure 3

  5. 5. Expel air bubble(s). Adjust the dose (if applicable).
  6. 6. Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration.
  7. 7. Discard the used syringe into an appropriate receptacle.

For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

U.S. Patents 9,731,082 and 10,661,018

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 202253 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ondansetron Injection

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Serotonin-3 Receptor Antagonist
Active ingredient Ondansetron hydrochloride 4 mg/2 mL
Dosage form Injection, solution
Route Intramuscular, Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) FRESENIUS KABI USA
FDA approval ANDA 202253Abbreviated New Drug Application (ANDA) – generic drug Approved July 19, 2013
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 17 labelers list this drug on DailyMed
Packages (NDC)
Package
4 mg/2 mL – 2 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-103-00
4 mg/2 mL – 2 ml in 1 syringe, glass / 1 in 1 blister pack / 24 in 1 carton NDC 76045-216-00

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.