Fluocinonide

Product NDC
50090-1784
11-digit product format
500901784
Labeler code
50090
Product ID
50090-1784_d04a497f-2bc7-414e-a490-c6938647f1c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA072488
Marketing category
ANDA
Marketing start
1990-09-30
Substance
FLUOCINONIDE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1784-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1784-0557ba5c1ecfa…9c80585c8c6e…

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
A072488-001FLUOCINONIDEFLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072488-001AB1

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 06:07:402026-07A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-063f01610625f2…
2019-09-15 20:21 UTC2019-09A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072488-001FLUOCINONIDE0.05%CREAM / TOPICALAB11989-02-06e64feba35796…

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 06:07:402026-07A072488-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072488-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072488-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072488-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072488-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072488-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072488-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072488-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072488-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072488-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072488-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072488-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072488-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072488-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072488-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072488-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072488-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072488-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072488-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072488-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072488-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072488-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A072488-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072488-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072488-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072488-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A072488-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A072488-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072488-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072488-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072488-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072488-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072488-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072488-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072488-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A072488-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A072488-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072488-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072488-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072488-001AB11e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINONIDE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2W4A77YPANInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce75f0e1-c536-40ad-b77f-2e3ec29caeb7Available on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1784-0Fluocinonide1 in 1 CARTONCREAM112
50090-1784-0Fluocinonide30 g in 1 TUBECREAM3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1784-0GM - Gram50090-1784da9496f8-d8e7-4b0e-890d-f17adb3841be12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1784FLUOCINONIDE CREAM [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20241107_ce75f0e1-c536-40ad-b77f-2e3ec29caeb7.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluocinonideFLUOCINONIDEA-S Medication Solutionsce75f0e1-c536-40ad-b77f-2e3ec29caeb72024-11-06Adverse reactionsExact identifier
application applno (ANDA): 072488
application number: ANDA072488
ndc (product): 50090-1784
FluocinonideFLUOCINONIDETeva Pharmaceuticals USA, Inc.986c1ba3-2103-4773-a35c-2c0121a017832024-09-30Adverse reactionsExact identifier
application applno (ANDA): 072488
application number: ANDA072488
FluocinonideFLUOCINONIDENuCare Pharmaceuticals, Inc.51cbe73c-e5d6-1e6a-e054-00144ff88e882024-08-14Adverse reactionsExact identifier
application applno (ANDA): 072488
application number: ANDA072488

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNce75f0e1-c536-40ad-b77f-2e3ec29caeb712
103456fluocinonide 0.5 MG/ML Topical CreamSCDce75f0e1-c536-40ad-b77f-2e3ec29caeb712
103456fluocinonide 0.05 % Topical CreamSYce75f0e1-c536-40ad-b77f-2e3ec29caeb712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1784-0500901784001 TUBE in 1 CARTON (50090-1784-0) / 30 g in 1 TUBE1 tube2015-04-170000-00-00NoNoCurrent