Isoproterenol Hydrochloride
Rx only These highlights do not include all the information needed to use ISOPROTERENOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ISOPROTERENOL HYDROCHLORIDE INJECTION. ISOPROTERENOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1956
Approved
Approval ID
56cb205c-8329-454a-a6be-e05e497de81e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2023
Manufacturers
FDA
Armas Pharmaceuticals Inc.
DUNS: 098405973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isoproterenol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72485-113
Application NumberANDA210845
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRACARDIAC
Effective DateAugust 9, 2021
FDA Product Classification
INGREDIENTS (8)
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT