Quick answers
- What is Procainamide hydrochloride used for?
- The FDA-approved label (Procainamide Hydrochloride, Remedyrepack Inc., August 31, 2026) says: “Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Procainamide hydrochloride have a boxed warning?
- Yes. The FDA label for Procainamide Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Procainamide hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Procainamide hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Procainamide hydrochloride?
- 10 companies list prescription products of Procainamide hydrochloride in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Sagent Pharmaceuticals and Caplin Steriles Limited.
What Procainamide hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. …
— FDA label: Procainamide Hydrochloride, Remedyrepack Inc., effective August 31, 2026. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
12 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 16 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Sagent Pharmaceuticals2 products
- Caplin Steriles Limited2 products
- Medical Purchasing Solutions, LLC2 products
- Nexus Pharmaceuticals LLC2 products
- Gland Pharma Limited2 products
- Hospira, Inc.1 product
- International Medication Systems, Limited1 product
- Remedyrepack Inc.1 product
- ProPharma Distribution1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA088636Intl Medication · July 31, 1984
- ANDA089069Hospira · February 12, 1986
- ANDA206332Nexus · October 13, 2017
- ANDA218135Gland · July 22, 2024
- ANDA218674Caplin · February 4, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 857886, 857962, 1862220 |
|---|---|
| SPL set ID of the quoted label | 1ec3b767-66bb-4634-877e-71f70d501da0 |
| FDA labels (SPL) | 12 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | PROCAINAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Procainamide Hydrochloride, Remedyrepack Inc., effective August 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →