Fluocinonide

Product NDC
40032-095
11-digit product format
400320095
Labeler code
40032
Product ID
40032-095_9eb4edbd-dc0b-48cc-b088-6d1871d61157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207538
Marketing category
ANDA
Marketing start
2017-07-31
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct40032-095IInactivated by FDA2026-08-17
excluded packagepackage40032-09540032-095-60IInactivated by FDA2026-08-17
excluded packagepackage40032-09540032-095-61IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage40032-095-61d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage40032-095-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40032-095-61f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40032-095-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage40032-095-612ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage40032-095-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage40032-095-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage40032-095-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage40032-095-61cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage40032-095-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage40032-095-61cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage40032-095-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage40032-095-61302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage40032-095-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage40032-095-61ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage40032-095-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage40032-095-610efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage40032-095-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage40032-095-61ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage40032-095-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage40032-095-61367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage40032-095-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage40032-095-61557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage40032-095-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage40032-095-618af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage40032-095-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage40032-095-61834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage40032-095-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage40032-095-611332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage40032-095-601332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207538-001FLUOCINONIDEFLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207538-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207538-001FLUOCINONIDE0.05%OINTMENT / TOPICALAB2017-07-31e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207538-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207538-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207538-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207538-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207538-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207538-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207538-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207538-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207538-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207538-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207538-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207538-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207538-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207538-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207538-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207538-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207538-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207538-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207538-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207538-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207538-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207538-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207538-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207538-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207538-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207538-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207538-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207538-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207538-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207538-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207538-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207538-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207538-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207538-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207538-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207538-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207538-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207538-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207538-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207538-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40032-095-602024-01-30C16284748780-11030e365-298e-111a-e063-dadaa90a10e2Fluocinonide Ointment USP, 0.05% Rx only
40032-095-612024-01-30C16284748780-11030e365-298e-111a-e063-dadaa90a10e2Fluocinonide Ointment USP, 0.05% Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-095-60Fluocinonide1 in 1 CARTONOINTMENT12
40032-095-60Fluocinonide15 g in 1 TUBEOINTMENT152
40032-095-61Fluocinonide1 in 1 CARTONOINTMENT12
40032-095-61Fluocinonide60 g in 1 TUBEOINTMENT602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-095FLUOCINONIDE OINTMENT [NOVEL LABORATORIES, INC.]2Legacy NDC, 4 package rows20171130_ee0ffda0-c09c-4f64-a7c6-efb1bb24eee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103457fluocinonide 0.05 % Topical OintmentPSNee0ffda0-c09c-4f64-a7c6-efb1bb24eee22
103457fluocinonide 0.0005 MG/MG Topical OintmentSCDee0ffda0-c09c-4f64-a7c6-efb1bb24eee22
103457fluocinonide 0.05 % Topical OintmentSYee0ffda0-c09c-4f64-a7c6-efb1bb24eee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-095-60400320095601 TUBE in 1 CARTON (40032-095-60) > 15 g in 1 TUBE1 tube2017-07-310000-00-00NoNoCurrent
40032-095-61400320095611 TUBE in 1 CARTON (40032-095-61) > 60 g in 1 TUBE1 tube2017-07-310000-00-00NoNoCurrent