FDA.reportPublic FDA data

loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension

RxCUI
545255
RxNorm name
loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension
Display name
loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension
Full name
loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loteprednol etabonate and tobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINBausch & Lomb Americas Inc.75df79e9-f064-4f46-9837-8d4d536517a32026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 545255
Loteprednol etabonate and TobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINAlembic Pharmaceuticals Limiteda6d68829-f7b6-4b9b-ad44-110c476099182025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 545255
Loteprednol etabonate and TobramycinLOTEPREDNOL ETABONATE AND TOBRAMYCINAlembic Pharmaceuticals Inc.7c752fac-8ec8-49ab-8570-09d2aabbeef02025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 545255
ZyletLOTEPREDNOL ETABONATE AND TOBRAMYCINBausch & Lomb Incorporated3dd9b060-5355-404d-bdf1-09ee8b52a9f52022-04-30Warnings, Adverse reactionsExact identifier
rxcui: 545255

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3dd9b060-5355-404d-bdf1-09ee8b52a9f5loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [PSN] · loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [SCD] · loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [SY]318These highlights do not include all the information needed to use ZYLET safely and effectively. See full prescribing information for ZYLET. ZYLET ® (loteprednol etabonate and tobramycin ophthalmic suspension) 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 200420220430
7c752fac-8ec8-49ab-8570-09d2aabbeef0loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [PSN] · loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [SCD] · loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [SY]36These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE and TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 200420251211
75df79e9-f064-4f46-9837-8d4d536517a3loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [PSN] · loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [SCD] · loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [SY]33These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE AND TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE AND TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE AND TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 200420260120
a6d68829-f7b6-4b9b-ad44-110c47609918loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [PSN] · loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [SCD] · loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic Suspension [SY]31These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE and TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 200420251215