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Data / Drug companies / Sertraline hydrochloride

Sertraline hydrochloride: 55 companies and 194 products in the FDA NDC directory

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

Sertraline hydrochloride is listed in the FDA National Drug Code Directory by 55 companies, with 194 products in commercial distribution. 185 of the products (95.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; capsule, and the newest product started marketing on October 16, 2026.

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Companies listing it
55
Products
194
Generic (ANDA) products
185 (95.4%)
Application numbers
18
Routes
Oral
Brand names
Zoloft, Sertraline HCl, Sertraline HCl, Finjozy, Sertraline
openFDA record search
api.fda.gov

Companies that list sertraline hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
A-S Medication Solutions22tablet, film coated; tabletGeneric drugs (ANDA)August 6, 2025
Bryant Ranch Prepack13tablet, film coated; tabletGeneric drugs (ANDA)August 6, 2025
Remedyrepack Inc.10tablet, film coated; tabletGeneric drugs (ANDA)July 21, 2026
Preferred Pharmaceuticals Inc.7tablet, film coatedGeneric drugs (ANDA)July 15, 2026
Coupler LLC6tablet, film coated; tabletGeneric drugs (ANDA)July 10, 2026
Lupin Pharmaceuticals, Inc.6tablet, film coatedGeneric drugs (ANDA)August 6, 2025
NuCare Pharmaceuticals,Inc.6tablet, film coated; tabletGeneric drugs (ANDA)May 3, 2021
Cipla USA Inc.5tablet; capsuleGeneric drugs (ANDA)July 17, 2025
PD-Rx Pharmaceuticals, Inc.5tablet, film coatedGeneric drugs (ANDA)February 6, 2007
Proficient Rx LP5tablet, film coatedGeneric drugs (ANDA)February 9, 2017
Aurobindo Pharma Limited4tablet, film coated; solution, concentrateGeneric drugs (ANDA)October 31, 2008
Cardinal Health 107, LLC4tablet; tablet, film coatedGeneric drugs (ANDA)April 3, 2017
NorthStar Rx LLC4tablet, film coated; solutionGeneric drugs (ANDA)October 31, 2008
St. Mary's Medical Park Pharmacy4tablet, film coatedGeneric drugs (ANDA)August 15, 2024
Viatris Specialty LLC4tablet, film coated; solution, concentrateNew drug applications (NDA)July 8, 2025
Accord Healthcare Inc.3tablet, film coatedGeneric drugs (ANDA)February 9, 2017
American Health Packaging3tabletGeneric drugs (ANDA)June 19, 2017
Aphena Pharma Solutions - Tennessee, LLC3tablet, film coated; tabletGeneric drugs (ANDA)February 9, 2017
Ascent Pharmaceuticals, Inc.3tabletGeneric drugs (ANDA)May 3, 2021
Asclemed USA, Inc.3tablet, film coatedGeneric drugs (ANDA)February 6, 2007
Aurobindo Pharma Limited3tablet, film coatedGeneric drugs (ANDA)November 20, 2025
AvPAK3tablet, film coatedGeneric drugs (ANDA)October 9, 2025
Camber Pharmaceuticals, Inc.3tabletGeneric drugs (ANDA)May 3, 2021
Granules Pharmaceuticals Inc.3tablet, film coatedGeneric drugs (ANDA)May 15, 2023
Legacy Pharmaceutical Packaging, LLC3tabletGeneric drugs (ANDA)July 21, 2016
Major Pharmaceuticals3tablet, film coatedGeneric drugs (ANDA)February 6, 2007
NCS HealthCare of Ky, LLC DBA Vangard Labs3tablet, film coatedGeneric drugs (ANDA)February 6, 2007
Northwind Health Company, LLC3tablet, film coated; tabletGeneric drugs (ANDA)June 17, 2020
PD-Rx Pharmaceuticals, Inc.3tablet; tablet, film coatedGeneric drugs (ANDA)February 9, 2017
Proficient Rx LP3tabletGeneric drugs (ANDA)July 21, 2016
ScieGen Pharmaceuticals, Inc.3tablet, film coatedGeneric drugs (ANDA)May 8, 2023
Unit Dose Solutions, Inc.3tablet, film coatedGeneric drugs (ANDA)July 8, 2026
XLCare Pharmaceuticals, Inc.3tabletGeneric drugs (ANDA)May 3, 2021
Advanced Rx of Tennessee, LLC2tablet, film coatedGeneric drugs (ANDA)April 7, 2023
Almatica Pharma LLC2capsuleNew drug applications (NDA)October 4, 2021
Alvogen Inc.2capsuleAuthorized generics (NDA)September 18, 2025
Ani Pharmaceuticals, Inc.2capsuleGeneric drugs (ANDA)January 20, 2026
Biocon Pharma Inc.2capsuleGeneric drugs (ANDA)January 30, 2026
Bryant Ranch Prepack2tablet, film coatedGeneric drugs (ANDA)February 6, 2007
Dr. Reddy's Laboratories Inc.2capsuleGeneric drugs (ANDA)January 15, 2026
QPharma, Inc.2tablet, film coatedGeneric drugs (ANDA)February 9, 2017
Quallent Pharmaceuticals Health LLC2tablet, film coatedGeneric drugs (ANDA)September 28, 2023
TruPharma, LLC2tablet, film coatedGeneric drugs (ANDA)October 16, 2026
Umedica Laboratories USA Inc.2capsuleGeneric drugs (ANDA)February 15, 2026
Zydus Lifesciences Limited2capsuleGeneric drugs (ANDA)January 29, 2026
Zydus Pharmaceuticals USA Inc.2capsuleGeneric drugs (ANDA)January 29, 2026
Aphena Pharma Solutions - Tennessee, LLC1tablet, film coatedGeneric drugs (ANDA)February 6, 2007
Bryant Ranch Prepack1solutionGeneric drugs (ANDA)June 30, 2006
Direct_Rx1tablet, film coatedGeneric drugs (ANDA)July 29, 2020
Method Pharmaceuticals, LLC1tabletGeneric drugs (ANDA)October 15, 2026
Mylan Pharmaceuticals Inc.1solution, concentrateAuthorized generics (NDA)May 15, 2018
Northwind Health Company, LLC1tablet, film coatedGeneric drugs (ANDA)February 11, 2026
Proficient Rx LP1tablet, film coatedGeneric drugs (ANDA)August 6, 2025
Quality Care Products, LLC1tablet, film coatedGeneric drugs (ANDA)February 6, 2007
Rising Pharma Holdings, Inc.1solution, concentrateGeneric drugs (ANDA)October 31, 2008

Dosage forms

Dosage formProductsShare
Tablet, film coated13268%
Tablet3819.6%
Capsule189.3%
Solution, concentrate42.1%
Solution21%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)18595.4%
New drug applications (NDA)63.1%
Authorized generics (NDA)31.5%

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.