Procainamide Hydrochloride
Procainamide Hydrochloride Injection, USP
Approved
Approval ID
d58751df-cd8b-45a6-8a32-af19e747e23a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2021
Manufacturers
FDA
Nexus Pharmaceuticals LLC
DUNS: 620714787
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Procainamide Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-900
Application NumberANDA206332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Procainamide Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (6)
Procainamide HydrochlorideActive
Quantity: 500 mg in 1 mL
Code: SI4064O0LX
Classification: ACTIB
MethylparabenInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
Sodium MetabisulfiteInactive
Quantity: 1.8 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Procainamide Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-901
Application NumberANDA206332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Procainamide Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (6)
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Procainamide HydrochlorideActive
Quantity: 100 mg in 1 mL
Code: SI4064O0LX
Classification: ACTIB
MethylparabenInactive
Quantity: 1 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
Sodium MetabisulfiteInactive
Quantity: 0.8 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT