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Data / Drug companies / Procainamide hydrochloride

Procainamide hydrochloride: 10 companies and 15 products in the FDA NDC directory

Procainamide hydrochloride is listed in the FDA National Drug Code Directory by 10 companies, with 15 products in commercial distribution. 15 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection, and the newest product started marketing on February 17, 2025.

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Companies listing it
10
Products
15
Generic (ANDA) products
15 (100.0%)
Application numbers
5
Routes
Intramuscular, Intravenous
openFDA record search
api.fda.gov

Companies that list procainamide hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Caplin Steriles Limited2injection, solutionGeneric drugs (ANDA)February 17, 2025
Gland Pharma Limited2injection, solutionGeneric drugs (ANDA)July 22, 2024
Medical Purchasing Solutions, LLC2injection, solutionGeneric drugs (ANDA)January 15, 2025
Nexus Pharmaceuticals LLC2injectionGeneric drugs (ANDA)October 14, 2007
Sagent Pharmaceuticals2injection, solutionGeneric drugs (ANDA)January 15, 2025
HF Acquisition Co LLC, DBA HealthFirst1injectionGeneric drugs (ANDA)June 23, 2023
Hospira, Inc.1injection, solutionGeneric drugs (ANDA)March 8, 2006
International Medication Systems, Limited1injectionGeneric drugs (ANDA)December 21, 2016
ProPharma Distribution1injectionGeneric drugs (ANDA)December 21, 2016
Remedyrepack Inc.1injectionGeneric drugs (ANDA)October 10, 2024

Dosage forms

Dosage formProductsShare
Injection, solution960%
Injection640%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)15100%

Pharmacologic classes

ClassProducts
Antiarrhythmic15

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.