Gentamicin Sulfate in Sodium Chloride
Gentamicin Sulfate in 0.9% Sodium Chloride Injection in Plastic Container VIAFLEX PLUS Container For Intravenous Administration Further Dilution Not Required
Approved
Approval ID
449c9a41-d61e-49fd-b5e3-d76f74b92acf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2023
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
Products 5
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 Code0338-0505
Application NumberANDA062373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 7, 2016
FDA Product Classification
INGREDIENTS (5)
GENTAMICIN SULFATEActive
Quantity: 100 mg in 100 mL
Code: 8X7386QRLV
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: IACT
Gentamicin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-0507
Application NumberANDA062373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 7, 2016
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 60 mg in 50 mL
Code: 8X7386QRLV
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 450 mg in 50 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Gentamicin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-0503
Application NumberANDA062373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 7, 2016
FDA Product Classification
INGREDIENTS (5)
GENTAMICIN SULFATEActive
Quantity: 80 mg in 100 mL
Code: 8X7386QRLV
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 900 mg in 100 mL
Code: 451W47IQ8X
Classification: IACT
Gentamicin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-0511
Application NumberANDA062373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 7, 2016
FDA Product Classification
INGREDIENTS (5)
GENTAMICIN SULFATEActive
Quantity: 100 mg in 50 mL
Code: 8X7386QRLV
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 450 mg in 50 mL
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Gentamicin Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0338-0509
Application NumberANDA062373
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 7, 2016
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 80 mg in 50 mL
Code: 8X7386QRLV
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 450 mg in 50 mL
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT