DOBUTAMINE
DOBUTamineINJECTION, USP
Approved
Approval ID
dc537761-d5f4-488d-24ab-b2bcd2b17b7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 26, 2019
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOBUTAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-2344
Application NumberANDA074086
Product Classification
M
Marketing Category
C73584
G
Generic Name
DOBUTAMINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 26, 2019
FDA Product Classification
INGREDIENTS (4)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 mL
Code: 0WR771DJXV
Classification: ACTIM
SODIUM METABISULFITEInactive
Quantity: 0.2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT