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Data / Drug companies / Amitriptyline hydrochloride

Amitriptyline hydrochloride: 35 companies and 204 products in the FDA NDC directory

Amitriptyline hydrochloride is listed in the FDA National Drug Code Directory by 35 companies, with 204 products in commercial distribution. 204 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, coated, and the newest product started marketing on October 29, 2026.

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Companies listing it
35
Products
204
Generic (ANDA) products
204 (100.0%)
Application numbers
11
Routes
Oral
openFDA record search
api.fda.gov

Companies that list amitriptyline hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
A-S Medication Solutions19tablet, film coated; tabletGeneric drugs (ANDA)November 1, 2025
Bryant Ranch Prepack18tablet, film coated; tabletGeneric drugs (ANDA)November 1, 2025
Remedyrepack Inc.11tablet; tablet, coatedGeneric drugs (ANDA)September 8, 2025
Preferred Pharmaceuticals Inc.9tablet, film coated; tabletGeneric drugs (ANDA)November 17, 2025
Advanced Rx of Tennessee, LLC7tablet, film coated; tabletGeneric drugs (ANDA)August 27, 2024
Aphena Pharma Solutions - Tennessee, LLC7tablet, film coatedGeneric drugs (ANDA)May 26, 2021
St. Mary's Medical Park Pharmacy7tablet; tablet, film coatedGeneric drugs (ANDA)October 29, 2026
Advagen Pharma Ltd6tablet, film coatedGeneric drugs (ANDA)May 1, 2023
AiPing Pharmaceutical, Inc.6tabletGeneric drugs (ANDA)November 1, 2025
Asclemed USA, Inc.6tablet, film coatedGeneric drugs (ANDA)May 26, 2021
Centaur Pharmaceuticals Private Limited6tabletGeneric drugs (ANDA)June 6, 2022
Coupler LLC6tablet, film coatedGeneric drugs (ANDA)August 21, 2026
Golden State Medical Supply, Inc.6tablet, film coatedGeneric drugs (ANDA)July 14, 1987
Lifestar Pharma LLC6tablet, film coatedGeneric drugs (ANDA)February 23, 2021
NorthStar Rx LLC6tablet, film coatedGeneric drugs (ANDA)August 25, 2021
Rising Pharma Holdings, Inc.6tabletGeneric drugs (ANDA)June 10, 2023
Sandoz Inc6tablet, film coatedGeneric drugs (ANDA)November 29, 1977
Sun Pharmaceutical Industries, Inc.6tablet, film coatedGeneric drugs (ANDA)July 14, 1987
Unichem Pharmaceuticals (USA), Inc.6tablet, film coatedGeneric drugs (ANDA)May 26, 2021
Westminster Pharmaceuticals, LLC6tablet, coatedGeneric drugs (ANDA)May 20, 2024
Zydus Lifesciences Limited6tablet, film coatedGeneric drugs (ANDA)December 26, 2017
Zydus Pharmaceuticals USA Inc.6tablet, film coatedGeneric drugs (ANDA)December 26, 2017
Aurobindo Pharma Limited5tablet, film coatedGeneric drugs (ANDA)March 20, 2026
AvPAK5tablet, film coatedGeneric drugs (ANDA)June 6, 2023
Northwind Health Company, LLC4tablet, film coatedGeneric drugs (ANDA)March 24, 2023
NuCare Pharmaceuticals,Inc.4tablet, film coated; tabletGeneric drugs (ANDA)June 10, 2023
Accord Healthcare Inc.3tablet, film coatedGeneric drugs (ANDA)December 26, 2014
Northwind Health Company, LLC3tablet, film coatedGeneric drugs (ANDA)November 26, 2025
Proficient Rx LP3tablet, film coatedGeneric drugs (ANDA)May 26, 2021
American Health Packaging2tablet, film coatedGeneric drugs (ANDA)August 15, 2019
Major Pharmaceuticals2tabletGeneric drugs (ANDA)March 8, 2024
PD-Rx Pharmaceuticals, Inc.2tablet, film coatedGeneric drugs (ANDA)November 29, 1977
PD-Rx Pharmaceuticals, Inc.1tablet, film coatedGeneric drugs (ANDA)May 26, 2021
Proficient Rx LP1tablet, film coatedGeneric drugs (ANDA)May 26, 2021
Proficient Rx LP1tablet, film coatedGeneric drugs (ANDA)December 5, 2014

Dosage forms

Dosage formProductsShare
Tablet, film coated14068.6%
Tablet4622.5%
Tablet, coated188.8%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)204100%

Pharmacologic classes

ClassProducts
Tricyclic Antidepressant204

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.