DOBUTAMINE IN DEXTROSE
Approved
Approval ID
3418aa46-2d9a-39f3-e063-6294a90a2961
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2025
Manufacturers
FDA
HF Acquisition Co. LLC, DBA HealthFirst
DUNS: 045657305
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DOBUTAMINE IN DEXTROSE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1664
Application NumberNDA020201
Product Classification
M
Marketing Category
C73594
G
Generic Name
DOBUTAMINE IN DEXTROSE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (7)
DEXTROSE MONOHYDRATEInactive
Quantity: 5 g in 100 mL
Code: LX22YL083G
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 25 mg in 100 mL
Code: 4VON5FNS3C
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DOBUTAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 100 mL
Code: 0WR771DJXV
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 10 mg in 100 mL
Code: 7FLD91C86K
Classification: IACT