ISOPROTERENOL
These highlights do not include all the information needed to use [ISOPROTERENOL HYDROCHOLRIDE INJECTION] safely and effectively. See full prescribing information for[ISOPROTERENOL HYDROCHOLRIDE INJECTION] Initial U.S. Approval:[1956]
Approved
Approval ID
f724120d-da28-4065-9e05-d7dd6afbb546
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2024
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 2
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 Code69097-521
Application NumberANDA210322
Product Classification
M
Marketing Category
C73584
G
Generic Name
isoproterenol hydrochloride
Product Specifications
Route of AdministrationINTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 14, 2024
FDA Product Classification
INGREDIENTS (9)
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID ACETATEInactive
Code: DSO12WL7AU
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
isoproterenol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-522
Application NumberANDA210322
Product Classification
M
Marketing Category
C73584
G
Generic Name
isoproterenol hydrochloride
Product Specifications
Route of AdministrationINTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 14, 2024
FDA Product Classification
INGREDIENTS (9)
CITRIC ACID ACETATEInactive
Code: DSO12WL7AU
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 1 mg in 5 mL
Code: DIA2A74855
Classification: ACTIB