Skip to the page

Data / Drug companies / Fluoxetine hydrochloride

Fluoxetine hydrochloride: 44 companies and 129 products in the FDA NDC directory

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

Fluoxetine hydrochloride is listed in the FDA National Drug Code Directory by 44 companies, with 129 products in commercial distribution. 126 of the products (97.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; tablet, coated; tablet, film coated, and the newest product started marketing on October 26, 2026.

The request: Get every company that lists fluoxetine hydrochloride in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.

SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.

Companies listing it
44
Products
129
Generic (ANDA) products
126 (97.7%)
Application numbers
16
Routes
Oral
Brand names
Fluoxetine, Prozac, Fluoxetine
openFDA record search
api.fda.gov

Companies that list fluoxetine hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
A-S Medication Solutions15capsuleGeneric drugs (ANDA)September 25, 2019
Bryant Ranch Prepack7tablet, coated; capsuleGeneric drugs (ANDA)August 22, 2016
Bryant Ranch Prepack7capsuleGeneric drugs (ANDA)March 16, 2015
Northwind Health Company, LLC6capsuleGeneric drugs (ANDA)October 4, 2022
NuCare Pharmaceuticals,Inc.5capsuleGeneric drugs (ANDA)March 16, 2015
Proficient Rx LP5capsuleGeneric drugs (ANDA)September 25, 2019
Remedyrepack Inc.5capsuleGeneric drugs (ANDA)July 31, 2025
ScieGen Pharmaceuticals, Inc.5capsule; tabletGeneric drugs (ANDA)September 11, 2025
Coupler LLC4capsuleGeneric drugs (ANDA)October 26, 2026
NorthStar Rx LLC4capsule; tablet, film coatedGeneric drugs (ANDA)September 18, 2019
Aurobindo Pharma Limited3capsuleGeneric drugs (ANDA)January 31, 2008
BluePoint Laboratories3capsuleGeneric drugs (ANDA)June 19, 2019
Bryant Ranch Prepack3tablet, coated; capsuleGeneric drugs (ANDA)August 22, 2016
Dista Products Company3capsuleNew drug applications (NDA)June 15, 1999
Lupin Pharmaceuticals, Inc.3tabletGeneric drugs (ANDA)August 7, 2019
Marksans Pharma Limited3capsuleGeneric drugs (ANDA)January 29, 2022
PD-Rx Pharmaceuticals, Inc.3capsuleGeneric drugs (ANDA)January 31, 2008
Preferred Pharmaceuticals Inc.3capsuleGeneric drugs (ANDA)May 18, 2021
Proficient Rx LP3capsuleGeneric drugs (ANDA)March 16, 2015
Quallent Pharmaceuticals Health LLC3capsuleGeneric drugs (ANDA)September 1, 2023
Radha Pharmaceuticals, Inc.3capsuleGeneric drugs (ANDA)October 24, 2022
Strides Pharma Inc.3capsuleGeneric drugs (ANDA)March 16, 2015
Time Cap Laboratories, Inc3capsuleGeneric drugs (ANDA)February 12, 2022
Alembic Pharmaceuticals Limited2tablet, film coatedGeneric drugs (ANDA)April 15, 2017
Aphena Pharma Solutions - Tennessee, LLC2capsuleGeneric drugs (ANDA)October 24, 2022
Calvin Scott & Co., Inc.2capsuleGeneric drugs (ANDA)March 16, 2015
Major Pharmaceuticals2capsuleGeneric drugs (ANDA)January 3, 2025
Pai Holdings, LLC DBA Pai Pharma2solutionGeneric drugs (ANDA)February 1, 2002
Par Health USA, LLC2tablet, coatedGeneric drugs (ANDA)August 22, 2016
American Health Packaging1capsuleGeneric drugs (ANDA)July 21, 2022
Ani Pharmaceuticals, Inc.1solutionGeneric drugs (ANDA)November 9, 2022
Aphena Pharma Solutions - Tennessee, LLC1capsuleGeneric drugs (ANDA)March 16, 2015
Cardinal Health 107, LLC1capsuleGeneric drugs (ANDA)December 4, 2024
Direct_Rx1capsuleGeneric drugs (ANDA)January 7, 2020
Dr. Reddy's Laboratories Inc.1tablet, film coatedGeneric drugs (ANDA)January 28, 2019
Dr. Reddy's Laboratories Limited1capsule, delayed release pelletsGeneric drugs (ANDA)March 24, 2010
Lannett Company, Inc.1liquidGeneric drugs (ANDA)August 27, 2009
Medsource Pharmaceuticals1capsuleGeneric drugs (ANDA)March 16, 2015
PD-Rx Pharmaceuticals, Inc.1capsuleGeneric drugs (ANDA)March 16, 2015
QPharma, Inc.1capsuleGeneric drugs (ANDA)January 31, 2008
Redpharm Drug1capsuleGeneric drugs (ANDA)March 16, 2015
St. Mary's Medical Park Pharmacy1capsuleGeneric drugs (ANDA)June 30, 2020
Sun Pharmaceutical Industries, Inc.1tablet, film coatedGeneric drugs (ANDA)February 15, 2019
Upsher-Smith Laboratories, LLC1for solutionGeneric drugs (ANDA)November 15, 2022

Dosage forms

Dosage formProductsShare
Capsule10480.6%
Tablet, coated97%
Tablet, film coated53.9%
Tablet53.9%
Solution32.3%
Liquid10.8%
For solution10.8%
Capsule, delayed release pellets10.8%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)12697.7%
New drug applications (NDA)32.3%

Pharmacologic classes

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.