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Data / Drug companies / Naltrexone hydrochloride

Naltrexone hydrochloride: 24 companies and 45 products in the FDA NDC directory

Naltrexone hydrochloride is listed in the FDA National Drug Code Directory by 24 companies, with 45 products in commercial distribution. 45 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, and the newest product started marketing on June 15, 2026.

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
24
Products
45
Generic (ANDA) products
45 (100.0%)
Application numbers
5
Routes
Oral
openFDA record search
api.fda.gov

Companies that list naltrexone hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack13tablet, film coatedGeneric drugs (ANDA)August 15, 2025
Bryant Ranch Prepack4tablet, film coatedGeneric drugs (ANDA)August 15, 2025
A-S Medication Solutions2tablet, film coatedGeneric drugs (ANDA)January 18, 2012
Aphena Pharma Solutions - Tennessee, LLC2tablet, film coatedGeneric drugs (ANDA)March 22, 2002
Aphena Pharma Solutions - Tennessee, LLC2tablet, film coatedGeneric drugs (ANDA)August 15, 2025
Coupler LLC2tablet, film coatedGeneric drugs (ANDA)June 15, 2026
Precision Dose, Inc.2tablet, film coatedGeneric drugs (ANDA)February 15, 2024
Remedyrepack Inc.2tablet, film coatedGeneric drugs (ANDA)May 20, 2025
Accord Healthcare Inc.1tablet, film coatedGeneric drugs (ANDA)January 18, 2012
American Health Packaging1tablet, film coatedGeneric drugs (ANDA)June 3, 2013
AvKARE1tablet, film coatedGeneric drugs (ANDA)March 26, 2015
Bryant Ranch Prepack1tablet, film coatedGeneric drugs (ANDA)September 23, 2013
Chartwell RX, LLC1tablet, film coatedGeneric drugs (ANDA)July 21, 2017
Elite Laboratories, Inc.1tablet, film coatedGeneric drugs (ANDA)August 15, 2025
Golden State Medical Supply, Inc.1tablet, film coatedGeneric drugs (ANDA)March 22, 2002
Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.1tablet, film coatedGeneric drugs (ANDA)October 6, 2023
Major Pharmaceuticals1tablet, film coatedGeneric drugs (ANDA)February 29, 2012
NCS HealthCare of Ky, LLC DBA Vangard Labs1tablet, film coatedGeneric drugs (ANDA)February 29, 2012
NuCare Pharmaceuticals,Inc.1tablet, film coatedGeneric drugs (ANDA)February 15, 2024
Proficient Rx LP1tablet, film coatedGeneric drugs (ANDA)February 29, 2012
Redpharm Drug1tablet, film coatedGeneric drugs (ANDA)January 18, 2012
SpecGx LLC1tablet, film coatedGeneric drugs (ANDA)March 22, 2002
Sun Pharmaceutical Industries, Inc.1tablet, film coatedGeneric drugs (ANDA)February 29, 2012
Tagi Pharma, Inc.1tablet, film coatedGeneric drugs (ANDA)September 23, 2013

Dosage forms

Dosage formProductsShare
Tablet, film coated45100%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)45100%

Pharmacologic classes

ClassProducts
Opioid Antagonist45

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.