FDA.reportPublic FDA data

Fluocinonide

Product NDC
69238-1271
Requested package NDC
69238-1271-3
11-digit product format
692381271
Labeler code
69238
Product ID
69238-1271_3f44c60e-c3a6-468c-92ba-f423cbd3fa06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211111
Marketing category
ANDA
Marketing start
2018-07-31
Marketing end
0000-00-00
Substance
FLUOCINONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69238-127169238-1271-3DDiscontinued by firm2026-08-17

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69238-127169238-1271-3DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A211111-001FLUOCINONIDEFLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04

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 06:07:402026-07A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211111-001FLUOCINONIDE0.1%CREAM / TOPICAL2018-06-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-043f01610625f2…
2019-09-15 20:21 UTC2019-09A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211111-001FLUOCINONIDE0.1%CREAM / TOPICALAB2018-06-04e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211111-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211111-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211111-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211111-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211111-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211111-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211111-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211111-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211111-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211111-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211111-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211111-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211111-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211111-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211111-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211111-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211111-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211111-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211111-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211111-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211111-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211111-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211111-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211111-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211111-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211111-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211111-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211111-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211111-001AB1cb3db0bc1861…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1271-2GM - Gram69238-1271b5c39173-09af-4fd4-9b00-51e6f6d41bda12018-11-06
69238-1271-3GM - Gram69238-12715b697eee-a300-4a8c-ac6b-5ecc053064bd12018-11-06
69238-1271-6GM - Gram69238-1271641e0ea7-1adc-4437-bddf-870feb33053212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1271FLUOCINONIDE CREAM [AMNEAL PHARMACEUTICALS NY LLC]8Legacy NDC20231231_41584f59-b641-4494-8b8e-7c845ac47335.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluocinonideFLUOCINONIDEAsclemed USA, Inc.b387f926-1109-41b2-9fe0-f77db6b102802022-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211111
application number: ANDA211111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485647fluocinonide 0.1 % Topical CreamPSNb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 1 MG/ML Topical CreamSCDb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 0.1 % Topical CreamSYb387f926-1109-41b2-9fe0-f77db6b102801
485647fluocinonide 1 MG per 1 GM Topical CreamSYb387f926-1109-41b2-9fe0-f77db6b102801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1271-3692381271031 TUBE in 1 CARTON (69238-1271-3) > 30 g in 1 TUBE1 tube2018-07-310000-00-00NoNoCurrent