Dobutamine
Dobutamine injection
Approved
Approval ID
ee09a55f-9992-48bb-b8d6-1184bd548536
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals
DUNS: 039452765
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 Code70436-203
Application NumberANDA216131
Product Classification
M
Marketing Category
C73584
G
Generic Name
dobutamine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 250 mg in 20 mL
Code: 0WR771DJXV
Classification: ACTIM