Home NDC 24208-507-07 Lotemax SM
Product NDC 24208-507
Requested package NDC 24208-507-07
11-digit product format 242080507
Labeler code 24208
Product ID 24208-507_4e5af379-3e45-420f-e063-6294a90a4ada
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name loteprednol etabonate
Dosage form GEL
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application NDA208219
Marketing category NDA
Marketing start 2019-02-25
Substance LOTEPREDNOL ETABONATE
Active strength 3.8 mg/g
Pharmacologic classes 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 1 .
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 N208219-001 LOTEMAX SM LOTEPREDNOL ETABONATE 0.38% GEL / OPHTHALMIC AB RLD, RS 2019-02-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N208219-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 N208219-001 12589069 2036-01-26 U-2764 Drug product 2026-04-30 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC AB RLD, RS 2019-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC AB RLD, RS 2019-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC AB RLD, RS 2019-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208219-001 LOTEMAX SM 0.38% GEL / OPHTHALMIC RLD, RS 2019-02-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208219-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208219-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208219-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208219-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 61 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208219-001 10596107 2036-12-23 U-2764 Drug product 2020-03-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208219-001 11534395 2036-01-26 U-2764 Drug product 2023-01-12 1c564ffb4f44…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Lotemax SM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 3.8 mg/g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2118537 Internal RxNorm lookup 2118539 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-507 LOTEMAX SM (LOTEPREDNOL ETABONATE) GEL [BAUSCH & LOMB INCORPORATED] 4 Current NDC, Legacy NDC, 6 package rows 20230531_6f9477b5-699f-4d3b-b9a6-0cc238266237.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24208-507-07 24208050707 1 BOTTLE in 1 CARTON (24208-507-07) / 5 g in 1 BOTTLE 1 bottle 2019-02-25 0000-00-00 No No Current