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Generic Indocin Availability

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

INDOCIN (indomethacin - capsule;oral)

  • Manufacturer: IROKO PHARMS LLC
    Approved Prior to Jan 1, 1982
    Strength(s): 25MG [RLD], 50MG [RLD]

INDOCIN (indomethacin - suppository;rectal)

  • Manufacturer: IROKO PHARMS
    Approval date: August 13, 1984
    Strength(s): 50MG [RLD]

INDOCIN (indomethacin - suspension;oral)

  • Manufacturer: IROKO PHARMS
    Approval date: October 10, 1985
    Strength(s): 25MG/5ML [RLD]

INDOCIN (indomethacin sodium - injectable;injection)

  • Manufacturer: RECORDATI RARE
    Approval date: January 30, 1985
    Strength(s): EQ 1MG BASE/VIAL [RLD] [AP]

Has a generic version of Indocin been approved?

Yes. The following products are equivalent to Indocin:

indomethacin sodium injectable;injection

  • Manufacturer: HOSPIRA INC
    Approval date: April 19, 2016
    Strength(s): EQ 1MG BASE/VIAL [AP]
  • Manufacturer: NAVINTA LLC
    Approval date: July 19, 2017
    Strength(s): EQ 1MG BASE/VIAL [AP]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: July 16, 2008
    Strength(s): EQ 1MG BASE/VIAL [AP]

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

  • indomethacin - capsule;oral
  • indomethacin - suppository;rectal
  • indomethacin - suspension;oral

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

Further information

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

Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.