Dobutamine
Approved
Approval ID
a0882db1-2532-4b80-b753-68f013fe79e7
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 Code54868-5717
Application NumberANDA074292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dobutamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 25, 2011
FDA Product Classification
INGREDIENTS (5)
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 mL
Code: 0WR771DJXV
Classification: ACTIB
SODIUM METABISULFITEInactive
Quantity: 0.24 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT