Dopamine Hydrochloride
Injection, USP
Approved
Approval ID
0e499952-46c7-4172-8c70-186312e240a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 4
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 Code0143-9253
Application NumberANDA207707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 6, 2022
FDA Product Classification
INGREDIENTS (4)
DOPAMINE HYDROCHLORIDEActive
Quantity: 80 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CITRATEInactive
Quantity: 5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID ACETATEInactive
Quantity: 10 mg in 1 mL
Code: DSO12WL7AU
Classification: IACT
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9254
Application NumberANDA207707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 6, 2022
FDA Product Classification
INGREDIENTS (4)
DOPAMINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
CITRIC ACID ACETATEInactive
Quantity: 10 mg in 1 mL
Code: DSO12WL7AU
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CITRATEInactive
Quantity: 5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9252
Application NumberANDA207707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 6, 2022
FDA Product Classification
INGREDIENTS (4)
DOPAMINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
CITRIC ACID ACETATEInactive
Quantity: 10 mg in 1 mL
Code: DSO12WL7AU
Classification: IACT
SODIUM CITRATEInactive
Quantity: 5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9255
Application NumberANDA207707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 6, 2022
FDA Product Classification
INGREDIENTS (4)
CITRIC ACID ACETATEInactive
Quantity: 10 mg in 1 mL
Code: DSO12WL7AU
Classification: IACT
DOPAMINE HYDROCHLORIDEActive
Quantity: 80 mg in 1 mL
Code: 7L3E358N9L
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 9 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM CITRATEInactive
Quantity: 5 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT