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Data / Drug companies / Duloxetine

Duloxetine: 36 companies and 144 products in the FDA NDC directory

Duloxetine is listed in the FDA National Drug Code Directory by 36 companies, with 144 products in commercial distribution. 137 of the products (95.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, delayed release; capsule, delayed release pellets, and the newest product started marketing on July 1, 2026.

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Companies listing it
36
Products
144
Generic (ANDA) products
137 (95.1%)
Application numbers
13
Routes
Oral
Brand names
Drizalma Sprinkle
openFDA record search
api.fda.gov

Companies that list duloxetine

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack11capsule, delayed release; capsule, delayed release pelletsGeneric drugs (ANDA)March 16, 2017
A-S Medication Solutions10capsule, delayed releaseGeneric drugs (ANDA)March 16, 2017
Preferred Pharmaceuticals Inc.8capsule, delayed release; capsule, delayed release pelletsGeneric drugs (ANDA)June 10, 2026
Remedyrepack Inc.8capsule, delayed releaseGeneric drugs (ANDA)August 14, 2025
Hawaii Repack, Inc.7capsule, delayed release; capsule, delayed release pelletsGeneric drugs (ANDA)March 25, 2019
Sun Pharmaceutical Industries, Inc.7capsule, delayed releaseNew drug applications (NDA)June 10, 2024
NuCare Pharmaceuticals,Inc.6capsule, delayed release; capsule, delayed release pelletsGeneric drugs (ANDA)March 16, 2017
Asclemed USA, Inc.5capsule, delayed release; capsule, delayed release pelletsGeneric drugs (ANDA)March 25, 2019
Proficient Rx LP5capsule, delayed release; capsule, delayed release pelletsGeneric drugs (ANDA)March 16, 2017
Advanced Rx of Tennessee, LLC4capsule, delayed releaseGeneric drugs (ANDA)October 22, 2024
Ajanta Pharma USA Inc.4capsule, delayed releaseGeneric drugs (ANDA)March 25, 2019
BluePoint Laboratories4capsule, delayed releaseGeneric drugs (ANDA)July 28, 2023
Golden State Medical Supply, Inc.4capsule, delayed releaseGeneric drugs (ANDA)December 11, 2013
Lupin Pharmaceuticals, Inc.4capsule, delayed releaseGeneric drugs (ANDA)May 25, 2015
Quallent Pharmaceuticals Health LLC4capsule, delayed releaseGeneric drugs (ANDA)July 1, 2025
Actavis Pharma, Inc.3capsule, delayed release pelletsGeneric drugs (ANDA)December 17, 2013
Alembic Pharmaceuticals Inc.3capsule, delayed releaseGeneric drugs (ANDA)April 9, 2026
Alembic Pharmaceuticals Limited3capsule, delayed releaseGeneric drugs (ANDA)June 9, 2014
Almatica Pharma LLC3capsule, delayed releaseNew drug applications (NDA)July 1, 2026
Ani Pharmaceuticals, Inc.3capsule, delayed releaseGeneric drugs (ANDA)December 5, 2015
Aphena Pharma Solutions - Tennessee, LLC3capsule, delayed releaseGeneric drugs (ANDA)March 16, 2017
Ascend Laboratories, LLC3capsule, delayed releaseGeneric drugs (ANDA)May 1, 2012
Asclemed USA Inc.3capsule, delayed releaseGeneric drugs (ANDA)March 25, 2019
Camber Pharmaceuticals, Inc.3capsule, delayed releaseGeneric drugs (ANDA)December 30, 2020
Coupler LLC3capsule, delayed releaseGeneric drugs (ANDA)September 22, 2025
Inventia Healthcare Limited3capsule, delayed releaseGeneric drugs (ANDA)December 5, 2015
NCS HealthCare of Ky, LLC DBA Vangard Labs3capsule, delayed releaseGeneric drugs (ANDA)December 11, 2013
Qingdao Baheal Pharmaceutical Co., Ltd.3capsule, delayed releaseGeneric drugs (ANDA)May 5, 2018
Solco Healthcare US, LLC3capsule, delayed releaseGeneric drugs (ANDA)January 20, 2016
St. Mary's Medical Park Pharmacy3capsule, delayed releaseGeneric drugs (ANDA)September 16, 2025
Zydus Lifesciences Limited3capsule, delayed releaseGeneric drugs (ANDA)May 27, 2014
Bryant Ranch Prepack1capsule, delayed release pelletsGeneric drugs (ANDA)December 17, 2013
Bryant Ranch Prepack1capsule, delayed release pelletsGeneric drugs (ANDA)December 17, 2013
Northwind Health Company, LLC1capsule, delayed releaseGeneric drugs (ANDA)April 23, 2021
PD-Rx Pharmaceuticals, Inc.1capsule, delayed releaseGeneric drugs (ANDA)March 16, 2017
QPharma, Inc.1capsule, delayed releaseGeneric drugs (ANDA)December 11, 2013

Dosage forms

Dosage formProductsShare
Capsule, delayed release13090.3%
Capsule, delayed release pellets149.7%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)13795.1%
New drug applications (NDA)74.9%

Pharmacologic classes

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