PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE INJ, USP 100MG/ML 10ML SYR
Approved
Approval ID
fece65c0-fdbc-61d8-e053-6294a90a9a68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
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 HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1630
Application NumberANDA088636
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROCAINAMIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (5)
SODIUM BISULFITEInactive
Quantity: 0.09 mg in 1 mL
Code: TZX5469Z6I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROCAINAMIDE HYDROCHLORIDEActive
Quantity: 100 mg in 1 mL
Code: SI4064O0LX
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 0.9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT