Gentamicin Sulfate
Gentamicin Sulfate Ophthalmic Solution USP Sterile Rx Only
Approved
Approval ID
a54e5c95-609d-4d66-9573-5d1ac78fa58f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 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 Code76420-137
Application NumberANDA062196
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gentamicin Sulfate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATEInactive
Code: SE337SVY37
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GENTAMICIN SULFATEActive
Quantity: 3 mg in 1 mL
Code: 8X7386QRLV
Classification: ACTIM