Desoximetasone

Product NDC
0168-0151
11-digit product format
001680151
Labeler code
0168
Product ID
0168-0151_aa08bd10-2801-4f27-82f1-c69c6a72418d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application
ANDA078657
Marketing category
ANDA
Marketing start
2012-09-28
Marketing end
0000-00-00
Substance
DESOXIMETASONE
Active strength
3 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct0168-0151DDiscontinued by firm2026-08-17
excluded packagepackage0168-01510168-0151-15DDiscontinued by firm2026-08-17
excluded packagepackage0168-01510168-0151-60DDiscontinued 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 · 36 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 packagepackage0168-0151-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0168-0151-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0151-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0168-0151-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0168-0151-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0168-0151-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0168-0151-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0168-0151-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0168-0151-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0168-0151-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0168-0151-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0168-0151-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0168-0151-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0168-0151-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0168-0151-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0168-0151-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0168-0151-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0168-0151-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0168-0151-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0168-0151-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0168-0151-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0168-0151-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0168-0151-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0168-0151-15557ba5c1ecfa…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
A078657-001DESOXIMETASONEDESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078657-001AB

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 06:07:402026-07A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078657-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2012-09-28e64feba35796…

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 06:07:402026-07A078657-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078657-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078657-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078657-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078657-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078657-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078657-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078657-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078657-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078657-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078657-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078657-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078657-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078657-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078657-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078657-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078657-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078657-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078657-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078657-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078657-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078657-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078657-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078657-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078657-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078657-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078657-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078657-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078657-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078657-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078657-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078657-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078657-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078657-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078657-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078657-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078657-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078657-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078657-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078657-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0151-15GM - Gram0168-015189ce1626-f3a9-45c1-969f-bb6f9bfa9f1412013-02-13
0168-0151-60GM - Gram0168-01513e40a807-288b-431d-ad65-e9dcba6d413012013-02-13

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0151-15001680151151 TUBE in 1 CARTON (0168-0151-15) > 15 g in 1 TUBE1 tube2012-09-280000-00-00NoNoCurrent
0168-0151-60001680151601 TUBE in 1 CARTON (0168-0151-60) > 60 g in 1 TUBE1 tube2012-09-280000-00-00NoNoCurrent