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
NDC Product Code69097-521
Application NumberANDA210322
Marketing CategoryC73584
Route of AdministrationINTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 14, 2024
Generic Nameisoproterenol hydrochloride
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
NDC Product Code69097-522
Application NumberANDA210322
Marketing CategoryC73584
Route of AdministrationINTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 14, 2024
Generic Nameisoproterenol hydrochloride
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