Gentamicin Sulfate
(Sterile)
Approved
Approval ID
b59e49e0-640b-43c3-ad07-711d1bb154e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2022
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-254
Application NumberANDA064048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 19, 2022
FDA Product Classification
INGREDIENTS (8)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 3 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT