Isoproterenol Hydrochloride
Approved
Approval ID
046f2941-3bc0-4755-861c-71bedb49e706
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2021
Manufacturers
FDA
Amring Pharmaceuticals Inc.
DUNS: 079843051
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 Code69918-731
Application NumberANDA211237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC
Effective DateMay 28, 2021
FDA Product Classification
INGREDIENTS (8)
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 2.5 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.0 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.2 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.07 mg in 1 mL
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Isoproterenol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69918-735
Application NumberANDA211237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isoproterenol Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRACARDIAC
Effective DateMay 28, 2021
FDA Product Classification
INGREDIENTS (8)
ISOPROTERENOL HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 mL
Code: DIA2A74855
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 2.07 mg in 1 mL
Code: B22547B95K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 2.5 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.0 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.2 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT