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
NDC Product Code0338-1009
Application NumberNDA019615
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2017
Generic NameDopamine Hydrochloride
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
NDC Product Code0338-1007
Application NumberNDA019615
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2017
Generic NameDopamine Hydrochloride
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
NDC Product Code0338-1005
Application NumberNDA019615
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJuly 14, 2017
Generic NameDopamine Hydrochloride
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