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Generic Zofran Availability

Last updated on Jun 8, 2022.

Zofran is a brand name of ondansetron, approved by the FDA in the following formulation(s):

ZOFRAN (ondansetron hydrochloride - injectable;injection)

  • Manufacturer: NOVARTIS
    Approval date: January 4, 1991
    Strength(s): EQ 2MG BASE/ML (discontinued) [RLD]

ZOFRAN (ondansetron hydrochloride - solution;oral)

  • Manufacturer: NOVARTIS
    Approval date: January 24, 1997
    Strength(s): EQ 4MG BASE/5ML [RLD] [AA]

ZOFRAN (ondansetron hydrochloride - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: December 31, 1992
    Strength(s): EQ 4MG BASE (discontinued) [RLD], EQ 8MG BASE (discontinued) [RLD]
  • Manufacturer: NOVARTIS
    Approval date: August 27, 1999
    Strength(s): EQ 24MG BASE (discontinued) [RLD]

Has a generic version of Zofran been approved?

Yes. The following products are equivalent to Zofran:

ondansetron hydrochloride solution;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: January 31, 2011
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: November 28, 2007
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: HIKMA
    Approval date: December 26, 2006
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: LANNETT CO INC
    Approval date: January 27, 2011
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: PHARM ASSOC
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: TARO
    Approval date: November 30, 2007
    Strength(s): EQ 4MG BASE/5ML [AA]

Note: No generic formulation of the following products are available.

  • ondansetron hydrochloride - injectable;injection
  • ondansetron hydrochloride - tablet;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zofran. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AA Products in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.