Home NDC 82260-358 Loteprednol etabonate and tobramycin
Product NDC 82260-358
11-digit product format 822600358
Labeler code 82260
Product ID 82260-358_48d4400d-e246-f109-e063-6394a90a8103
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name loteprednol etabonate and tobramycin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA050804
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-01-09
Substance LOTEPREDNOL ETABONATE; TOBRAMYCIN
Active strength 5; 3 mg/mL; mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050804-001 ZYLET LOTEPREDNOL ETABONATE; TOBRAMYCIN 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 2004-12-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050804-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 2004-12-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 2004-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 2004-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 2004-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050804-001 ZYLET 0.5%;0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2004-12-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Loteprednol etabonate and tobramycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 5 mg/mL TOBRAMYCIN 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YEH1EZ96K6 Internal UNII lookup VZ8RRZ51VK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545255 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82260-358-05 Loteprednol etabonate and tobramycin 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 3 82260-358-05 Loteprednol etabonate and tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 3 82260-358-10 Loteprednol etabonate and tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 3 82260-358-10 Loteprednol etabonate and tobramycin 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 3
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82260-358-05 82260035805 1 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPER 2026-01-09 No No Current 82260-358-10 82260035810 1 BOTTLE, DROPPER in 1 CARTON (82260-358-10) / 10 mL in 1 BOTTLE, DROPPER 2026-01-09 No No Current