Home NDC 99207-850 Luzu
Product NDC 99207-850
11-digit product format 992070850
Labeler code 99207
Product ID 99207-850_f18334bd-5ed1-43b2-87ba-80b803b54387
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LULICONAZOLE
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA204153
Marketing category NDA
Marketing start 2013-11-14
Substance LULICONAZOLE
Active strength 10 mg/g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA]
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 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 N204153-001 LUZU LULICONAZOLE 1% CREAM / TOPICAL RLD, RS 2013-11-14
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 N204153-001 8980931 2034-04-28 Drug product 2015-03-23
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 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204153-001 LUZU 1% CREAM / TOPICAL RLD, RS 2013-11-14 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 170 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 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204153-001 9012484 2033-09-06 U-540 Drug substance, Drug product 2015-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204153-001 9199977 2033-09-06 Drug substance, Drug product 2016-02-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204153-001 9453006 2033-09-06 Drug substance 2016-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204153-001 8980931 2034-04-28 Drug product 2015-03-23 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Luzu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LULICONAZOLE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RE91AN4S8G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1482684 Internal RxNorm lookup 1482689 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 99207-850 LUZU (LULICONAZOLE) CREAM [BAUSCH HEALTH US, LLC] 12 Current NDC, Legacy NDC, 4 package rows 20200607_a7016010-ce43-4c09-8d21-aeb697ffed31.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 Marketing end Sample Exclude flag Status 99207-850-02 99207085002 12 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE 12 tube 2013-11-14 0000-00-00 Yes No Current 99207-850-60 99207085060 1 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBE 1 tube 2013-11-14 0000-00-00 No No Current