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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204153-001LUZULULICONAZOLE1%CREAM / TOPICALRLD, RS2013-11-14

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-22
N204153-00191999772033-09-06Drug substance, Drug product2016-02-05
N204153-00194530062033-09-06Drug substance2016-09-29
N204153-00189809312034-04-28Drug product2015-03-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N204153-001LUZU1%CREAM / TOPICALRLD, RS2013-11-14cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204153-00191999772033-09-06Drug substance, Drug product2016-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204153-00194530062033-09-06Drug substance2016-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204153-00189809312034-04-28Drug product2015-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204153-00191999772033-09-06Drug substance, Drug product2016-02-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204153-00194530062033-09-06Drug substance2016-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204153-00189809312034-04-28Drug product2015-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204153-00191999772033-09-06Drug substance, Drug product2016-02-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204153-00194530062033-09-06Drug substance2016-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204153-00189809312034-04-28Drug product2015-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204153-00191999772033-09-06Drug substance, Drug product2016-02-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204153-00194530062033-09-06Drug substance2016-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204153-00189809312034-04-28Drug product2015-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204153-00191999772033-09-06Drug substance, Drug product2016-02-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204153-00194530062033-09-06Drug substance2016-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204153-00189809312034-04-28Drug product2015-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204153-00191999772033-09-06Drug substance, Drug product2016-02-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204153-00194530062033-09-06Drug substance2016-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204153-00189809312034-04-28Drug product2015-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204153-00191999772033-09-06Drug substance, Drug product2016-02-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204153-00194530062033-09-06Drug substance2016-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204153-00189809312034-04-28Drug product2015-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204153-00191999772033-09-06Drug substance, Drug product2016-02-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204153-00194530062033-09-06Drug substance2016-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204153-00189809312034-04-28Drug product2015-03-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204153-00191999772033-09-06Drug substance, Drug product2016-02-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204153-00194530062033-09-06Drug substance2016-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204153-00189809312034-04-28Drug product2015-03-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204153-00190124842033-09-06U-540Drug substance, Drug product2015-04-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N204153-00191999772033-09-06Drug substance, Drug product2016-02-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N204153-00194530062033-09-06Drug substance2016-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N204153-00189809312034-04-28Drug product2015-03-23d06236e962d9…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N204153-001NPP2021-02-2074a2ff9319b5…
2021-12-28 21:50 UTC2021-12N204153-001NPP2021-02-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204153-001NPP2021-02-2087673890dc5c…
2021-03-12 10:30 UTC2021-03N204153-001NPP2021-02-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204153-001NPP2021-02-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204153-001NPP2021-02-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204153-001NPP2021-02-203f01610625f2…
2019-09-15 20:21 UTC2019-09N204153-001NPP2021-02-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N204153-001NPP2021-02-20ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Luzu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LULICONAZOLE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RE91AN4S8GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1482684Internal RxNorm lookup
1482689Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7016010-ce43-4c09-8d21-aeb697ffed31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5984a8e6-24e4-43b7-9512-346486417e1eProduct name120180515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
99207-850-02Luzu12 in 1 CARTONCREAM1213
99207-850-02Luzu2 g in 1 TUBECREAM213
99207-850-60Luzu60 g in 1 TUBECREAM6013
99207-850-60Luzu1 in 1 CARTONCREAM113

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
99207-850LUZU (LULICONAZOLE) CREAM [BAUSCH HEALTH US, LLC]12Current NDC, Legacy NDC, 4 package rows20200607_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LULICONAZOLELULICONAZOLEOceanside Pharmaceuticals7ccda3ba-9c98-468d-83c6-7f0cc7c88c332020-04-30Adverse reactionsExact identifier
application applno (NDA): 204153
application number: NDA204153
LuzuLULICONAZOLEBausch Health US, LLCa7016010-ce43-4c09-8d21-aeb697ffed312020-04-01Adverse reactionsExact identifier
application applno (NDA): 204153
application number: NDA204153
ndc (product): 99207-850

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482684luliconazole 1 % Topical CreamPSNa7016010-ce43-4c09-8d21-aeb697ffed3113
1482689Luzu 1 % Topical CreamPSNa7016010-ce43-4c09-8d21-aeb697ffed3113
1482689luliconazole 10 MG/ML Topical Cream [Luzu]SBDa7016010-ce43-4c09-8d21-aeb697ffed3113
1482684luliconazole 10 MG/ML Topical CreamSCDa7016010-ce43-4c09-8d21-aeb697ffed3113
1482684luliconazole 1 % Topical CreamSYa7016010-ce43-4c09-8d21-aeb697ffed3113
1482689Luzu 1 % Topical CreamSYa7016010-ce43-4c09-8d21-aeb697ffed3113
1482689Luzu 10 MG/ML Topical CreamSYa7016010-ce43-4c09-8d21-aeb697ffed3113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
99207-850-029920708500212 TUBE in 1 CARTON (99207-850-02) / 2 g in 1 TUBE12 tube2013-11-140000-00-00YesNoCurrent
99207-850-60992070850601 TUBE in 1 CARTON (99207-850-60) / 60 g in 1 TUBE1 tube2013-11-140000-00-00NoNoCurrent