DOPamine Hydrochloride
These highlights do not include all the information needed to use DOPAMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOPAMINE HYDROCHLORIDE INJECTION. Initial U.S. Approval: 1974
Approved
Approval ID
1f306ad2-3606-4525-5a8a-ce78f426c1a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-9104
Application NumberNDA018132
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM METABISULFITEInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Quantity: 10 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 5 mg in 1 mL
Code: B22547B95K
Classification: IACT
DOPAMINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-5820
Application NumberNDA018132
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM METABISULFITEInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
DOPAMINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Quantity: 10 mg in 1 mL
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Quantity: 5 mg in 1 mL
Code: B22547B95K
Classification: IACT