Fluocinonide

Product NDC
50090-7923
11-digit product format
500907923
Labeler code
50090
Product ID
50090-7923_e76e19e7-5084-41c0-9c1e-fbc795df2fd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA210554
Marketing category
ANDA
Marketing start
2017-10-01
Substance
FLUOCINONIDE
Active strength
.5 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 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
A210554-001FLUOCINONIDEFLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210554-001AB1

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 06:07:402026-07A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICAL2018-08-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICAL2018-08-213f01610625f2…
2019-09-15 20:21 UTC2019-09A210554-001FLUOCINONIDE0.05%CREAM / TOPICAL2018-08-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A210554-001FLUOCINONIDE0.05%CREAM / TOPICAL2018-08-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB1RS2018-08-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210554-001FLUOCINONIDE0.05%CREAM / TOPICALAB12018-08-21e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210554-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210554-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210554-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210554-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210554-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210554-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210554-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210554-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210554-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210554-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210554-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210554-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210554-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210554-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210554-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210554-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210554-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210554-001AB114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210554-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210554-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210554-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A210554-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210554-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210554-001AB11c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210554-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210554-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210554-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210554-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210554-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210554-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210554-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A210554-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A210554-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210554-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210554-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210554-001AB11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210554-001AB11cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210554-001AB11a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinonide
Listing expiration
2027-12-31

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
ab79df76-192b-422e-8d2c-dd5a46ffb216Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a338afdd-91bc-4c45-5113-8b445b8e6cf2Product name520200618
f3bf4e6e-291f-4372-8e90-b4047949153aProduct name320200514
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
934e8c63-e34a-6dfb-4224-efad2d76fafcProduct name520190405
ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfeProduct name120181219
ef1d202f-16bf-4f17-a390-087db27f5314Product name120181203
de14082b-1b4a-48ac-b75c-4ee3ff8a29beProduct name120180809
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7923-0Fluocinonide1 in 1 CARTONCREAM12
50090-7923-0Fluocinonide15 g in 1 TUBECREAM152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7923-0GM - Gram50090-7923f2fdc067-3acb-4169-b38c-b8a60622c38712026-04-20

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 Solutionsab79df76-192b-422e-8d2c-dd5a46ffb2162026-03-06Adverse reactionsExact identifier
application applno (ANDA): 210554
application number: ANDA210554
ndc (product): 50090-7923
FluocinonideFLUOCINONIDEA-S Medication Solutionsb1b4a6e9-814e-41e9-9f35-8bed7595265b2026-02-08Adverse reactionsExact identifier
application applno (ANDA): 210554
application number: ANDA210554
Fluocinonide CreamFLUOCINONIDEAmneal Pharmaceuticals NY LLC817cac6b-fec5-406d-aa0c-8852d08a3c652023-06-06Adverse reactionsExact identifier
application applno (ANDA): 210554
application number: ANDA210554

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103456fluocinonide 0.05 % Topical CreamPSNab79df76-192b-422e-8d2c-dd5a46ffb2162
103456fluocinonide 0.5 MG/ML Topical CreamSCDab79df76-192b-422e-8d2c-dd5a46ffb2162
103456fluocinonide 0.05 % Topical CreamSYab79df76-192b-422e-8d2c-dd5a46ffb2162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7923-0500907923001 TUBE in 1 CARTON (50090-7923-0) / 15 g in 1 TUBE1 tube2026-03-04NoNoCurrent