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Data / Drug companies / Difluprednate ophthalmic

Difluprednate ophthalmic: 5 companies and 5 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Difluprednate ophthalmic is listed in the FDA National Drug Code Directory by 5 companies, with 5 products in commercial distribution. 4 of the products (80.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are emulsion, and the newest product started marketing on January 26, 2026.

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Companies listing it
5
Products
5
Generic (ANDA) products
4 (80.0%)
Application numbers
4
Routes
Ophthalmic
Brand names
Difluprednate
openFDA record search
api.fda.gov

Companies that list difluprednate ophthalmic

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Alembic Pharmaceuticals Inc.1emulsionGeneric drugs (ANDA)January 26, 2026
Alembic Pharmaceuticals Limited1emulsionGeneric drugs (ANDA)January 26, 2026
Amneal Pharmaceuticals NY LLC1emulsionGeneric drugs (ANDA)November 18, 2021
Dr. Reddy's Laboratories Inc.1emulsionGeneric drugs (ANDA)December 25, 2022
Sandoz Inc1emulsionAuthorized generics (NDA)May 15, 2013

Dosage forms

Dosage formProductsShare
Emulsion5100%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)480%
Authorized generics (NDA)120%

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.