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Data / Drug companies / Promethazine hydrochloride

Promethazine hydrochloride: 49 companies and 125 products in the FDA NDC directory

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

Promethazine hydrochloride is listed in the FDA National Drug Code Directory by 49 companies, with 125 products in commercial distribution. 125 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection; suppository, and the newest product started marketing on August 19, 2026.

The request: Get every company that lists promethazine hydrochloride 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
49
Products
125
Generic (ANDA) products
125 (100.0%)
Application numbers
17
Routes
Oral, Intramuscular, Intravenous, Rectal
Brand names
Phenergan, Promethegan
openFDA record search
api.fda.gov

Companies that list promethazine hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Hikma Pharmaceuticals USA Inc.13injectionGeneric drugs (ANDA)September 19, 1973
A-S Medication Solutions12tablet; suppositoryGeneric drugs (ANDA)June 22, 2022
NuCare Pharmaceuticals,Inc.6tabletGeneric drugs (ANDA)July 31, 2006
PD-Rx Pharmaceuticals, Inc.6tablet; suppositoryGeneric drugs (ANDA)March 3, 2011
Asclemed USA, Inc.5tablet; suppositoryGeneric drugs (ANDA)June 27, 2006
Northwind Health Company, LLC4tabletGeneric drugs (ANDA)October 4, 2023
Amneal Pharmaceuticals LLC3tabletGeneric drugs (ANDA)March 3, 2011
Amneal Pharmaceuticals of New York LLC3tabletGeneric drugs (ANDA)June 22, 2022
Asclemed USA Inc.3tabletGeneric drugs (ANDA)December 14, 2005
BluePoint Laboratories3tabletGeneric drugs (ANDA)January 13, 2014
Bryant Ranch Prepack3tabletGeneric drugs (ANDA)May 4, 2007
Cosette Pharmaceuticals, Inc.3suppositoryGeneric drugs (ANDA)February 28, 2004
Henry Schein, Inc.3injectionGeneric drugs (ANDA)January 17, 2022
KVK-Tech, Inc.3tabletGeneric drugs (ANDA)May 4, 2007
Proficient Rx LP3tabletGeneric drugs (ANDA)January 13, 2014
Remedyrepack Inc.3tabletGeneric drugs (ANDA)July 31, 2025
Sportpharm LLC3tabletGeneric drugs (ANDA)December 14, 2005
Zydus Lifesciences Limited3tabletGeneric drugs (ANDA)December 14, 2005
Zydus Pharmaceuticals USA Inc.3tabletGeneric drugs (ANDA)December 14, 2005
Actavis Pharma, Inc.2tabletGeneric drugs (ANDA)September 21, 1973
Atlantic Biologicals Corp.2syrupGeneric drugs (ANDA)April 7, 2025
Bryant Ranch Prepack2solutionGeneric drugs (ANDA)February 20, 2024
Camber Pharmaceuticals, Inc.2suppositoryGeneric drugs (ANDA)November 2, 2022
Cardinal Health 107, LLC2injection; tabletGeneric drugs (ANDA)July 2, 2024
Coupler LLC2tabletGeneric drugs (ANDA)July 6, 2026
Medical Purchasing Solutions, LLC2injectionGeneric drugs (ANDA)September 19, 1973
Padagis Israel Pharmaceuticals Ltd2suppositoryGeneric drugs (ANDA)June 27, 2006
ProPharma Distribution2injection; injection, solutionGeneric drugs (ANDA)January 30, 2015
XGen Pharmaceuticals DJB, Inc.2injection, solutionGeneric drugs (ANDA)January 30, 2015
Advanced Rx of Tennessee, LLC1tabletGeneric drugs (ANDA)February 15, 2023
American Health Packaging1tabletGeneric drugs (ANDA)June 20, 2022
American Health Packaging1tabletGeneric drugs (ANDA)August 30, 2006
Bryant Ranch Prepack1tabletGeneric drugs (ANDA)December 14, 2005
Chartwell Governmental & Specialty RX, LLC.1solutionGeneric drugs (ANDA)September 25, 1998
Chartwell RX, LLC1solutionGeneric drugs (ANDA)September 25, 1998
Cranbury Pharmaceuticals, LLC1syrupGeneric drugs (ANDA)June 8, 2012
Direct_Rx1tabletGeneric drugs (ANDA)February 9, 2021
Kesin Pharma Corporation1solutionGeneric drugs (ANDA)December 31, 2024
Major Pharmaceuticals1tabletGeneric drugs (ANDA)April 17, 2023
NCS HealthCare of Ky, LLC DBA Vangard Labs1tabletGeneric drugs (ANDA)July 2, 2018
Northwind Health Company, LLC1tabletGeneric drugs (ANDA)August 19, 2026
PD-Rx Pharmaceuticals, Inc.1suppositoryGeneric drugs (ANDA)February 28, 2002
Pai Holdings, LLC DBA Pai Pharma1solutionGeneric drugs (ANDA)August 7, 2025
Preferred Pharmaceuticals Inc.1tabletGeneric drugs (ANDA)April 16, 2021
Proficient Rx LP1tabletGeneric drugs (ANDA)September 19, 1973
Quagen Pharmaceuticals LLC1solutionGeneric drugs (ANDA)July 12, 2021
Redpharm Drug1tabletGeneric drugs (ANDA)December 14, 2005
Unit Dose Solutions, Inc.1tabletGeneric drugs (ANDA)July 1, 2026
Xttrium Laboratories, Inc.1syrupGeneric drugs (ANDA)April 7, 2025

Dosage forms

Dosage formProductsShare
Tablet7761.6%
Injection2116.8%
Suppository129.6%
Solution75.6%
Syrup54%
Injection, solution32.4%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)125100%

Pharmacologic classes

ClassProducts
Phenothiazine125

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.