Dopamine Hydrochloride and Dextrose
DOPamine Hydrochloride and 5% Dextrose Injection, USPin Plastic ContainerVIAFLEX Plus Container
Approved
Approval ID
cb97d4a0-89ed-407c-a763-209386b6f75c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2020
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 3
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 Code0338-1009
Application NumberNDA019615
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2017
FDA Product Classification
INGREDIENTS (5)
DOPAMINE HYDROCHLORIDEActive
Quantity: 320 mg in 100 mL
Code: 7L3E358N9L
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM BISULFITEInactive
Quantity: 0.5 meq in 100 mL
Code: TZX5469Z6I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1007
Application NumberNDA019615
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2017
FDA Product Classification
INGREDIENTS (5)
DOPAMINE HYDROCHLORIDEActive
Quantity: 160 mg in 100 mL
Code: 7L3E358N9L
Classification: ACTIB
SODIUM BISULFITEInactive
Quantity: 0.5 meq in 100 mL
Code: TZX5469Z6I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
Dopamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1005
Application NumberNDA019615
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dopamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2017
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM BISULFITEInactive
Quantity: 0.5 meq in 100 mL
Code: TZX5469Z6I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
DOPAMINE HYDROCHLORIDEActive
Quantity: 80 mg in 100 mL
Code: 7L3E358N9L
Classification: ACTIB