ISOPROTERENOL HYDROCHLORIDE
Rx only Sterile Injection
Approved
Approval ID
86b2455a-0489-405e-bd0b-9f79d3c5350d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 16, 2018
Manufacturers
FDA
Amphastar Pharmaceuticals, Inc.
DUNS: 024736733
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 Code0548-9502
Application NumberANDA210106
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC
Effective DateJuly 16, 2018
FDA Product Classification
INGREDIENTS (8)
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
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
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Isoproterenol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0548-9501
Application NumberANDA210106
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC
Effective DateJuly 16, 2018
FDA Product Classification
INGREDIENTS (8)
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT