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Generic Edecrin Availability

Last updated on Nov 8, 2022.

Edecrin is a brand name of ethacrynic acid, approved by the FDA in the following formulation(s):

EDECRIN (ethacrynate sodium - injectable;injection)

  • Manufacturer: BAUSCH
    Approved Prior to Jan 1, 1982
    Strength(s): EQ 50MG BASE/VIAL [RLD] [AP]

EDECRIN (ethacrynic acid - tablet;oral)

  • Manufacturer: BAUSCH
    Approved Prior to Jan 1, 1982
    Strength(s): 25MG [RLD] [AB], 50MG (discontinued)

Has a generic version of Edecrin been approved?

Yes. The following products are equivalent to Edecrin:

ethacrynate sodium injectable;injection

    Approval date: August 23, 2016
    Strength(s): EQ 50MG BASE/VIAL [AP]
  • Manufacturer: PAR STERILE PRODUCTS
    Approval date: July 29, 2015
    Strength(s): EQ 50MG BASE/VIAL [AP]
  • Manufacturer: VPI PHARMS INC
    Approval date: June 9, 2020
    Strength(s): EQ 50MG BASE/VIAL [AP]
  • Manufacturer: ZYDUS PHARMS
    Approval date: November 17, 2017
    Strength(s): EQ 50MG BASE/VIAL [AP]

ethacrynic acid tablet;oral

  • Manufacturer: AGNITIO
    Approval date: July 12, 2019
    Strength(s): 25MG [AB]
  • Manufacturer: AMNEAL PHARMS CO
    Approval date: May 8, 2018
    Strength(s): 25MG [AB]
  • Manufacturer: EDENBRIDGE PHARMS
    Approval date: June 30, 2016
    Strength(s): 25MG [AB]
  • Manufacturer: HIKMA
    Approval date: February 23, 2017
    Strength(s): 25MG [AB]
  • Manufacturer: LUPIN LTD
    Approval date: September 6, 2019
    Strength(s): 25MG [AB]
  • Manufacturer: PAR PHARM INC
    Approval date: July 21, 2017
    Strength(s): 25MG [AB]
  • Manufacturer: SCIEGEN PHARMS INC
    Approval date: August 27, 2019
    Strength(s): 25MG [AB]
  • Manufacturer: STRIDES PHARMA
    Approval date: October 19, 2020
    Strength(s): 25MG [AB]
  • Manufacturer: UPSHER SMITH LABS
    Approval date: February 19, 2020
    Strength(s): 25MG [AB]

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


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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
AP Injectable 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.

Further information

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