FDA.reportPublic FDA data

Procainamide Hydrochloride

Manufacturer
AX Pharmaceutical Corp
Effective date
2021-02-01
Label type
BULK INGREDIENT
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:54:08

Label at a glance#

ProductProcainamide Hydrochloride
Active ingredientPROCAINAMIDE HYDROCHLORIDE
Label structure1 sections

Label contents#

Full prescribing information#

Procainamide Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73377-055PROCAINAMIDE HYDROCHLORIDE POWDER [AX PHARMACEUTICAL CORP]2Unmatched20210203_c9dcf10a-a478-4da6-b6ab-b10f834fffdd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73377-05573377-055-01, 73377-055-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROCAINAMIDE HYDROCHLORIDESI4064O0LXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEREMEDYREPACK INC.1ec3b767-66bb-4634-877e-71f70d501da02026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEHospira, Inc.17e47845-daad-434c-a784-6d3875b0d7042026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstfece65c0-fdbc-61d8-e053-6294a90a9a682026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROCAINAMIDE HYDROCHLORIDE
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDENexus Pharmaceuticals LLCd58751df-cd8b-45a6-8a32-af19e747e23a2025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLC.42405567-3d04-7aec-e063-6294a90aba0a2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEProPharma Distribution3d5d9d6e-1f1c-7565-e063-6394a90a93e72025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDECaplin Steriles Limitedfcaa5e9a-3c8a-4796-aa87-626268b6cf602025-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDESagent Pharmaceuticals358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a2024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEGland Pharma Limitedffde440f-7ad7-434c-bcd2-9bd8ff16d2042024-07-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEMedical Purchasing Solutions, LLC0aac32fa-37b7-5520-e063-6394a90a1fe42023-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE
Procainamide HydrochloridePROCAINAMIDE HYDROCHLORIDEInternational Medication Systems, Limitedd7cb1594-61cf-41c4-9007-1ee28aa69c502016-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Procainamide Hydrochloride
generic name: PROCAINAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.