Gentamicin
Gentamicin Injection, USP
Approved
Approval ID
0cce2238-28d3-4280-b520-ffc3067a2ffa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GENTAMICIN SULFATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-010
Application NumberANDA062366
Product Classification
M
Marketing Category
C73584
G
Generic Name
GENTAMICIN SULFATE
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (7)
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 3.2 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 40 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM