MedPath

PROCAINAMIDE HCI

PROCAINAMIDE HCI INJECTION, USP 500mg/mL 2mL VIAL

Approved
Approval ID

9508d1a2-da9a-5480-e053-2a95a90a73c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 24, 2023

Manufacturers
FDA

HF Acquisition Co LLC, DBA HealthFirst

DUNS: 045657305

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PROCAINAMIDE HCI

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51662-1392
Application NumberANDA089070
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROCAINAMIDE HCI
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 24, 2023
FDA Product Classification

INGREDIENTS (6)

PROCAINAMIDE HYDROCHLORIDEActive
Quantity: 500 mg in 1 mL
Code: SI4064O0LX
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 1.8 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.