Procainamide Hydrochloride
PROCAINAMIDE HYDROCHLORIDE
Approved
Approval ID
17e47845-daad-434c-a784-6d3875b0d704
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-1902
Application NumberANDA089069
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROCAINAMIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 28, 2023
FDA Product Classification
INGREDIENTS (6)
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROCAINAMIDE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-1903
Application NumberANDA089070
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROCAINAMIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 28, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
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