FDA.reportPublic FDA data

loteprednol etabonate 0.5 % Ophthalmic Gel

RxCUI
1312625
RxNorm name
loteprednol etabonate 0.5 % Ophthalmic Gel
Display name
loteprednol etabonate 0.5 % Ophthalmic Gel
Full name
loteprednol etabonate 0.5 % Ophthalmic Gel
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loteprednol EtabonateLOTEPREDNOL ETABONATESentiss Pharmaceuticals LLC1fb8140b-c5a3-40eb-8429-2e570921917b2026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 1312625
Loteprednol EtabonateLOTEPREDNOL ETABONATEBausch & Lomb Americas Inc.cc8638ae-0444-4a8b-bcad-fa946f607b5d2025-02-04Warnings, Adverse reactionsExact identifier
rxcui: 1312625
LOTEMAXLOTEPREDNOL ETABONATEBausch & Lomb Incorporated9a666065-d467-42b8-8ecd-0ec1de9986d52024-10-24Warnings, Adverse reactionsExact identifier
rxcui: 1312625
Loteprednol EtabonateLOTEPREDNOL ETABONATEARMAS PHARMACEUTICALS INC.091a068f-f9b0-b02b-e063-6294a90a95e62023-10-25Warnings, Adverse reactionsExact identifier
rxcui: 1312625
Loteprednol EtabonateLOTEPREDNOL ETABONATEBausch & Lomb Incorporated7bbdbd31-5a8f-4d69-aa8e-5b700895e8042021-03-31Warnings, Adverse reactionsExact identifier
rxcui: 1312625

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9a666065-d467-42b8-8ecd-0ec1de9986d5loteprednol etabonate 0.5 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.005 MG/MG Ophthalmic Gel [SCD] · loteprednol etabonate 0.5 % Ophthalmic Gel [SY]312These highlights do not include all the information needed to use LOTEMAX safely and effectively. See full prescribing information for LOTEMAX. LOTEMAX ® (loteprednol etabonate ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 199820241024
cc8638ae-0444-4a8b-bcad-fa946f607b5dloteprednol etabonate 0.5 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.005 MG/MG Ophthalmic Gel [SCD] · loteprednol etabonate 0.5 % Ophthalmic Gel [SY]35These 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 use Initial U.S. Approval: 199820250204
1fb8140b-c5a3-40eb-8429-2e570921917bloteprednol etabonate 0.5 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.005 MG/MG Ophthalmic Gel [SCD] · loteprednol etabonate 0.5 % Ophthalmic Gel [SY]32These 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 use Initial U.S. Approval: 199820260415
7bbdbd31-5a8f-4d69-aa8e-5b700895e804loteprednol etabonate 0.5 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.005 MG/MG Ophthalmic Gel [SCD] · loteprednol etabonate 0.5 % Ophthalmic Gel [SY]32These 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 0.5%, for topical ophthalmic use. Initial U.S. Approval: 199820210331
091a068f-f9b0-b02b-e063-6294a90a95e6loteprednol etabonate 0.5 % Ophthalmic Gel [PSN] · loteprednol etabonate 0.005 MG/MG Ophthalmic Gel [SCD] · loteprednol etabonate 0.5 % Ophthalmic Gel [SY]31These 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 use Initial U.S. Approval: 199820231025