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Generic Carac Availability

Last updated on Sep 8, 2021.

Carac is a brand name of fluorouracil topical, approved by the FDA in the following formulation(s):

CARAC (fluorouracil - cream;topical)

  • Manufacturer: VALEANT PHARMS NORTH
    Approval date: October 27, 2000
    Strength(s): 0.5% [RLD]

Has a generic version of Carac been approved?

An Authorized Generic version of Carac 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:

  • fluorouracil TOPICAL CREAM 5 mg/g
    Mylan Pharmaceuticals Inc.
    NDC Code: 003788078

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

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Fluorouracil-containing formulation
    Patent 6,670,335
    Issued: December 30, 2003
    Inventor(s): B. Sandhya; Singh & Subhash J.; Saxena
    Assignee(s): A. P. Pharma, Inc.

    Oil-in-water emulsion formulations contain both free fluorouracil and fluorouracil impregnated in porous microparticles. The formulations are suitable for topical administration, and are useful for the treatment of solar keratoses, actinic keratoses, and superficial basal cell carcinomas.

    Patent expiration dates:

    • June 2, 2021
      Drug product


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.