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