Loteprednol Etabonate
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE OPHTHALMIC GEL safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE OPHTHALMIC GEL. LOTEPREDNOL ETABONATE OPHTHALMIC GEL, for topical ophthalmic useInitial U.S. Approval: 1998
Approved
Approval ID
cc8638ae-0444-4a8b-bcad-fa946f607b5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2023
Manufacturers
FDA
Bausch & Lomb Americas Inc.
DUNS: 118287629
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
loteprednol etabonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82260-508
Application NumberNDA202872
Product Classification
M
Marketing Category
C73605
G
Generic Name
loteprednol etabonate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 30, 2023
FDA Product Classification
INGREDIENTS (11)
LOTEPREDNOL ETABONATEActive
Quantity: 5 mg in 1 g
Code: YEH1EZ96K6
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
POLYCARBOPHILInactive
Code: W25LM17A4W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT