Dobutamine Hydrochloride
Approved
Approval ID
c0dd68b3-20af-464d-b3ba-34eb886df6ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-5777
Application NumberNDA020201
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dobutamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 25, 2011
FDA Product Classification
INGREDIENTS (7)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 400 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIB
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 25 mg in 100 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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