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Generic Diastat Availability

Last updated on Oct 6, 2021.

See also: Generic Diastat AcuDial

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

DIASTAT (diazepam - gel;rectal)

  • Manufacturer: BAUSCH
    Approval date: July 29, 1997
    Strength(s): 2.5MG/0.5ML (5MG/ML) [RLD], 5MG/ML (5MG/ML) (discontinued) [RLD], 10MG/2ML (5MG/ML) (discontinued) [RLD], 15MG/3ML (5MG/ML) (discontinued) [RLD], 20MG/4ML (5MG/ML) (discontinued) [RLD]

Has a generic version of Diastat been approved?

An Authorized Generic version of Diastat has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Diazepam RECTAL GEL 10 mg/2mL
    Teva Pharmaceuticals USA, Inc.
    NDC Code: 000936138
  • Diazepam RECTAL GEL 2.5 mg/.5mL
    Oceanside Pharmaceuticals
    NDC Code: 686820650
  • diazepam RECTAL GEL 10 mg/2mL
    Oceanside Pharmaceuticals
    NDC Code: 686820652
  • Diazepam RECTAL GEL 20 mg/4mL
    Oceanside Pharmaceuticals
    NDC Code: 686820655

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Diastat. 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.

Further information

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

Medical Disclaimer