Desoximetasone

Product NDC
68462-531
11-digit product format
684620531
Labeler code
68462
Product ID
68462-531_15a31bdf-5162-42bd-a3d5-7e21bac5f49f
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
Substance
DESOXIMETASONE
Active strength
2.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202838-001DESOXIMETASONE0.25%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…
2022-10-28 04:53 UTC2022-10A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202838-001DESOXIMETASONE0.25%OINTMENT / TOPICALABRS2013-09-20e64feba35796…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Desoximetasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE2.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4E07GXB7AUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197575Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea742af6-9359-46c3-9164-ab53e8c1461eAvailable on FDA.report

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]6Current NDC, Legacy NDC, 2 package rows20240104_ea742af6-9359-46c3-9164-ab53e8c1461e.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
DesoximetasoneDESOXIMETASONEGlenmark Pharmaceuticals Inc., USAea742af6-9359-46c3-9164-ab53e8c1461e2018-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202838
application number: ANDA202838
ndc (product): 68462-531

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