Home NDC 82260-299 Loteprednol Etabonate
Product NDC 82260-299
11-digit product format 822600299
Labeler code 82260
Product ID 82260-299_316eb8c8-48a7-a4b0-e063-6294a90a0bad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name loteprednol etabonate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA020583
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-04-07
Substance LOTEPREDNOL ETABONATE
Active strength 5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020583-001 LOTEMAX LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020583-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020583-001 LOTEMAX 0.5% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-03-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Loteprednol Etabonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YEH1EZ96K6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311382 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 82260-299-05 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 5 82260-299-05 Loteprednol Etabonate 5 mL in 1 BOTTLE SUSPENSION/ DROPS 5 5 82260-299-10 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 5 82260-299-10 Loteprednol Etabonate 10 mL in 1 BOTTLE SUSPENSION/ DROPS 10 5 82260-299-15 Loteprednol Etabonate 15 mL in 1 BOTTLE SUSPENSION/ DROPS 15 5 82260-299-15 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-299 LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [BAUSCH & LOMB AMERICAS INC.] 5 Current NDC, 6 package rows 20250331_f09b1206-97c7-4f21-bda8-94f55128c5cb.zip
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 Units Marketing start Sample Exclude flag Status 82260-299-05 82260029905 1 BOTTLE in 1 CARTON (82260-299-05) / 5 mL in 1 BOTTLE 1 bottle 2023-04-07 No No Current 82260-299-10 82260029910 1 BOTTLE in 1 CARTON (82260-299-10) / 10 mL in 1 BOTTLE 1 bottle 2023-04-07 No No Current 82260-299-15 82260029915 1 BOTTLE in 1 CARTON (82260-299-15) / 15 mL in 1 BOTTLE 1 bottle 2023-04-07 No No Current