Dobutamine Hydrochloride in Dextrose
DOBUTamine Hydrochloride in 5% Dextrose Injection in Plastic Container Viaflex Plus Container
Approved
Approval ID
6b17b98b-e06d-42ed-925f-69aa2699dead
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2023
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.
Dobutamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1077
Application NumberNDA020255
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (6)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 400 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIM
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
SODIUM BISULFITEInactive
Quantity: 0.5 meq in 100 mL
Code: TZX5469Z6I
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dobutamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1075
Application NumberNDA020255
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM BISULFITEInactive
Quantity: 0.5 meq in 100 mL
Code: TZX5469Z6I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 200 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIM
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Dobutamine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-1073
Application NumberNDA020255
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (6)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIM
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM BISULFITEInactive
Quantity: 0.5 meq in 100 mL
Code: TZX5469Z6I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT