Gentamicin
Gentamicin Injection, USP
Approved
Approval ID
60ca1487-392d-4721-aa45-3de38722896c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gentamicin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-403
Application NumberANDA215237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 24, 2021
FDA Product Classification
INGREDIENTS (8)
GENTAMICIN SULFATEActive
Quantity: 40 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
Gentamicin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-402
Application NumberANDA215237
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 24, 2021
FDA Product Classification
INGREDIENTS (8)
GENTAMICIN SULFATEActive
Quantity: 40 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT