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FDA Approval

Dobutamine Hydrochloride in Dextrose

CompanyA-S Medication Solutions (DUNS: 830016429)

Effective Date

April 15, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dobutamine(400 mg in 100 mL)

Manufacturing Establishments (1)

A-S Medication Solutions

Labeler

A-S Medication Solutions

DUNS Number

830016429

Products (1)

Dobutamine Hydrochloride in Dextrose

NDC Product Code

50090-4562

Application Number

NDA020255

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

March 27, 2019

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM BISULFITEInactive

Code: TZX5469Z6IClass: IACTQuantity: 0.5 meq in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

DobutamineActive

Code: 0WR771DJXVClass: ACTIMQuantity: 400 mg in 100 mL

DEXTROSE MONOHYDRATEInactive

Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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