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Data / Drug companies / Quetiapine fumarate

Quetiapine fumarate: 33 companies and 190 products in the FDA NDC directory

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

Quetiapine fumarate is listed in the FDA National Drug Code Directory by 33 companies, with 190 products in commercial distribution. 190 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; tablet, extended release, and the newest product started marketing on July 19, 2026.

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

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Companies listing it
33
Products
190
Generic (ANDA) products
190 (100.0%)
Application numbers
14
Routes
Oral
openFDA record search
api.fda.gov

Companies that list quetiapine fumarate

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack20tablet, film coated; tabletGeneric drugs (ANDA)July 1, 2016
Remedyrepack Inc.13tablet, film coated; tabletGeneric drugs (ANDA)July 19, 2026
A-S Medication Solutions9tablet; tablet, film coatedGeneric drugs (ANDA)July 1, 2016
Preferred Pharmaceuticals Inc.8tablet; tablet, film coatedGeneric drugs (ANDA)April 11, 2025
Aurobindo Pharma Limited7tablet, film coatedGeneric drugs (ANDA)March 27, 2012
Rising Pharma Holdings, Inc.7tablet, film coatedGeneric drugs (ANDA)March 27, 2012
Alembic Pharmaceuticals Limited6tablet, film coatedGeneric drugs (ANDA)February 21, 2017
AvPAK6tabletGeneric drugs (ANDA)May 26, 2016
Camber Pharmaceuticals, Inc.6tablet, film coatedGeneric drugs (ANDA)June 16, 2022
Golden State Medical Supply, Inc.6tabletGeneric drugs (ANDA)March 27, 2012
Hikma Pharmaceuticals USA Inc.6tabletGeneric drugs (ANDA)March 27, 2012
Lupin Pharmaceuticals, Inc.6tabletGeneric drugs (ANDA)March 27, 2012
Macleods Pharmaceuticals Limited6tablet, film coatedGeneric drugs (ANDA)June 14, 2016
NCS HealthCare of Ky, LLC DBA Vangard Labs6tablet, film coatedGeneric drugs (ANDA)July 1, 2016
Sun Pharmaceutical Industries, Inc.6tablet, film coatedGeneric drugs (ANDA)March 28, 2012
Unichem Pharmaceuticals (USA), Inc.6tablet, film coatedGeneric drugs (ANDA)July 1, 2016
XLCare Pharmaceuticals, Inc.6tablet, film coatedGeneric drugs (ANDA)February 2, 2024
Accord Healthcare Inc.5tablet, extended releaseGeneric drugs (ANDA)January 1, 2019
Aphena Pharma Solutions - Tennessee, LLC5tabletGeneric drugs (ANDA)March 27, 2012
Direct_Rx5tablet, film coated; tabletGeneric drugs (ANDA)May 30, 2023
Ingenus Pharmaceuticals, LLC5tablet, extended releaseGeneric drugs (ANDA)August 31, 2017
NorthStar Rx LLC5tablet, film coatedGeneric drugs (ANDA)March 27, 2012
NuCare Pharmaceuticals,Inc.5tablet, film coated; tabletGeneric drugs (ANDA)July 1, 2016
Coupler LLC4tablet, film coated; tabletGeneric drugs (ANDA)April 27, 2026
Novast Laboratories, Ltd.4tablet, extended releaseGeneric drugs (ANDA)August 31, 2017
Quallent Pharmaceuticals Health LLC4tabletGeneric drugs (ANDA)July 14, 2023
Advanced Rx of Tennessee, LLC3tablet; tablet, film coatedGeneric drugs (ANDA)July 11, 2024
Bryant Ranch Prepack3tablet, film coatedGeneric drugs (ANDA)March 28, 2012
Proficient Rx LP3tabletGeneric drugs (ANDA)March 1, 2013
Proficient Rx LP3tablet, film coatedGeneric drugs (ANDA)March 26, 2012
St. Mary's Medical Park Pharmacy3tablet; tablet, film coatedGeneric drugs (ANDA)May 21, 2025
Proficient Rx LP2tablet; tablet, film coatedGeneric drugs (ANDA)March 1, 2013
Unit Dose Solutions, Inc.1tabletGeneric drugs (ANDA)July 6, 2026

Dosage forms

Dosage formProductsShare
Tablet, film coated11057.9%
Tablet6634.7%
Tablet, extended release147.4%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)190100%

Pharmacologic classes

ClassProducts
Atypical Antipsychotic190

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.