Dobutamine in Dextrose
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Approved
Approval ID
9943a961-3b50-4847-8a84-d8414ce38daa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2021
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dobutamine in Dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-3724
Application NumberNDA020201
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine in Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 3, 2021
FDA Product Classification
INGREDIENTS (7)
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 400 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIM
SODIUM METABISULFITEInactive
Quantity: 25 mg in 100 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 10 mg in 100 mL
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Dobutamine in Dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-2346
Application NumberNDA020201
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine in Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 3, 2021
FDA Product Classification
INGREDIENTS (7)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 100 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
SODIUM METABISULFITEInactive
Quantity: 25 mg in 100 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 10 mg in 100 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Dobutamine in Dextrose
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-2347
Application NumberNDA020201
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine in Dextrose
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 3, 2021
FDA Product Classification
INGREDIENTS (7)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 200 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 25 mg in 100 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 10 mg in 100 mL
Code: 7FLD91C86K
Classification: IACT