Desoximetasone

Product NDC
68462-531
11-digit product format
684620531
Labeler code
68462
Product ID
68462-531_94619a44-0fe1-4878-9fc9-3e94de5ffbba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA202838
Marketing category
ANDA
Marketing start
2013-09-20
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
2020-12-31
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 productproduct68462-531DDiscontinued by firm2026-10-30
excluded packagepackage68462-53168462-531-17DDiscontinued by firm2026-10-30
excluded packagepackage68462-53168462-531-65DDiscontinued by firm2026-10-30

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A202838-001DESOXIMETASONEDESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-20

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-20c2088c7a36db…
2026-09-14 22:38:342026-08A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-2084e616aacf4f…
2026-08-18 06:07:402026-07A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICAL2013-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALAB2013-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-203a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202838-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202838-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202838-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202838-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202838-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202838-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202838-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202838-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202838-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202838-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202838-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202838-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202838-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202838-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202838-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202838-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202838-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202838-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202838-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202838-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202838-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202838-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202838-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202838-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202838-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202838-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202838-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202838-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202838-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202838-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202838-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202838-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202838-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202838-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202838-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202838-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202838-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-531-17Desoximetasone15 g in 1 TUBEOINTMENT156
68462-531-65Desoximetasone60 g in 1 TUBEOINTMENT606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-531-17GM - Gram68462-53103f983db-9f6e-442a-9073-784ca225ba6b12013-11-04
68462-531-65GM - Gram68462-531af9e0a54-6a1f-4e12-94b6-f7804970558312013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESOXIMETASONEACTIVE INGREDIENT4E07GXB7AUDESOXIMETASONE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]4
DESOXIMETASONEACTIVE MOIETY4E07GXB7AUDESOXIMETASONE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]4
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDESOXIMETASONE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UDESOXIMETASONE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-531DESOXIMETASONE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]6Legacy NDC, 2 package rows20240104_ea742af6-9359-46c3-9164-ab53e8c1461e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197575desoximetasone 0.25 % Topical OintmentPSNea742af6-9359-46c3-9164-ab53e8c1461e6
197575desoximetasone 0.0025 MG/MG Topical OintmentSCDea742af6-9359-46c3-9164-ab53e8c1461e6
197575desoximetasone 0.25 % Topical OintmentSYea742af6-9359-46c3-9164-ab53e8c1461e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-531-176846205311715 g in 1 TUBE (68462-531-17) 15 g2013-09-200000-00-00NoNoCurrent
68462-531-656846205316560 g in 1 TUBE (68462-531-65) 60 g2013-09-200000-00-00NoNoCurrent