Desoximetasone

Product NDC
53002-9280
11-digit product format
530029280
Labeler code
53002
Product ID
53002-9280_5e754839-fa0b-4ba0-8fce-a9da60e340a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA205082
Marketing category
ANDA
Marketing start
2016-03-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-9280IInactivated by FDA2026-08-17
excluded packagepackage53002-928053002-9280-1IInactivated 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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-9280-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-9280-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-9280-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-9280-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-9280-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-9280-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-9280-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-9280-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-9280-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53002-9280-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53002-9280-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A205082-001DESOXIMETASONEDESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205082-001AB

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 06:07:402026-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043f01610625f2…
2019-09-15 20:21 UTC2019-09A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205082-001DESOXIMETASONE0.25%CREAM / TOPICALAB2015-09-04e64feba35796…

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 06:07:402026-07A205082-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205082-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205082-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205082-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205082-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205082-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205082-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205082-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205082-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205082-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205082-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205082-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205082-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205082-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205082-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205082-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205082-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205082-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205082-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205082-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205082-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205082-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A205082-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205082-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205082-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205082-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205082-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205082-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205082-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205082-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205082-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205082-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205082-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205082-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205082-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205082-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205082-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205082-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205082-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205082-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83e6065d-d4c9-f323-882e-7de38bb4d6acProduct name920200701
7b3bb32e-bbfd-11d9-a253-bc78b5f7d7beProduct name320190204
08e04f33-a0f6-279a-7d07-56df7c40d693Product name320180605
d67f22fb-500c-d680-0b1d-d0de623f55e7Product name720171113

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9280-1Desoximetasone15 g in 1 TUBECREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9280DESOXIMETASONE CREAM [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_24f3d9cc-5376-4d8e-b113-9e675bd0ceec.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
DesoximetasoneDESOXIMETASONEProficient Rx LPf30b6fcc-43bc-4d65-9c3b-8d6ca780a0242022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205082
application number: ANDA205082

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197574desoximetasone 0.25 % Topical CreamPSN24f3d9cc-5376-4d8e-b113-9e675bd0ceec5
197574desoximetasone 2.5 MG/ML Topical CreamSCD24f3d9cc-5376-4d8e-b113-9e675bd0ceec5
197574desoximetasone 0.25 % Topical CreamSY24f3d9cc-5376-4d8e-b113-9e675bd0ceec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9280-15300292800115 g in 1 TUBE (53002-9280-1) 15 g2018-10-010000-00-00NoNoCurrent