Desoximetasone

Product NDC
51672-1396
11-digit product format
516721396
Labeler code
51672
Product ID
51672-1396_39702ff5-c8de-79c1-e063-6294a90a6dfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
SPRAY
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA204141
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-04-11
Substance
DESOXIMETASONE
Active strength
2.5 mg/mL
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
N204141-001TOPICORTDESOXIMETASONE0.25%SPRAY / TOPICALATRLD, RS2013-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N204141-001AT

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204141-00187156242026-05-26U-1408Drug product2014-06-13
N204141-00182777802028-09-01U-1408Drug product2013-06-26

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 06:07:402026-07N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N204141-001TOPICORT0.25%SPRAY / TOPICALATRLD, RS2013-04-11e64feba35796…

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 06:07:402026-07N204141-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204141-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204141-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204141-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204141-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204141-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204141-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204141-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204141-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204141-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204141-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204141-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204141-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204141-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204141-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204141-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204141-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204141-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204141-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204141-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204141-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204141-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N204141-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204141-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204141-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204141-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N204141-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N204141-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204141-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204141-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204141-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204141-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204141-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204141-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204141-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N204141-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N204141-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204141-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204141-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N204141-001AT1e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204141-00187156242026-05-26U-1408Drug product2014-06-13caaa826d4ba7…
2026-08-18 06:07:402026-07N204141-00182777802028-09-01U-1408Drug product2013-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204141-00187156242026-05-26U-1408Drug product2014-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204141-00182777802028-09-01U-1408Drug product2013-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204141-00187156242026-05-26U-1408Drug product2014-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204141-00182777802028-09-01U-1408Drug product2013-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N204141-00187156242026-05-26U-1408Drug product2014-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204141-00182777802028-09-01U-1408Drug product2013-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204141-00187156242026-05-26U-1408Drug product2014-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204141-00182777802028-09-01U-1408Drug product2013-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204141-00187156242026-05-26U-1408Drug product2014-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204141-00182777802028-09-01U-1408Drug product2013-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204141-00187156242026-05-26U-1408Drug product2014-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204141-00182777802028-09-01U-1408Drug product2013-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204141-00187156242026-05-26U-1408Drug product2014-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204141-00182777802028-09-01U-1408Drug product2013-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204141-00187156242026-05-26U-1408Drug product2014-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204141-00182777802028-09-01U-1408Drug product2013-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204141-00187156242026-05-26U-1408Drug product2014-06-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204141-00182777802028-09-01U-1408Drug product2013-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204141-00187156242026-05-26U-1408Drug product2014-06-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N204141-00182777802028-09-01U-1408Drug product2013-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204141-00187156242026-05-26U-1408Drug product2014-06-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204141-00182777802028-09-01U-1408Drug product2013-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204141-00187156242026-05-26U-1408Drug product2014-06-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204141-00182777802028-09-01U-1408Drug product2013-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204141-00187156242026-05-26U-1408Drug product2014-06-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204141-00182777802028-09-01U-1408Drug product2013-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204141-00187156242026-05-26U-1408Drug product2014-06-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204141-00182777802028-09-01U-1408Drug product2013-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204141-00187156242026-05-26U-1408Drug product2014-06-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204141-00182777802028-09-01U-1408Drug product2013-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204141-00187156242026-05-26U-1408Drug product2014-06-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204141-00182777802028-09-01U-1408Drug product2013-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204141-00187156242026-05-26U-1408Drug product2014-06-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204141-00182777802028-09-01U-1408Drug product2013-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204141-00187156242026-05-26U-1408Drug product2014-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204141-00182777802028-09-01U-1408Drug product2013-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204141-00187156242026-05-26U-1408Drug product2014-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204141-00182777802028-09-01U-1408Drug product2013-06-26bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE2.5 mg/mL

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
1376338Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b046ab97-ba1a-4be6-a238-09670b38b397Available 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
51672-1396-3Desoximetasone1 in 1 CARTONSPRAY15
51672-1396-3Desoximetasone30 mL in 1 BOTTLE, SPRAYSPRAY305
51672-1396-4Desoximetasone1 in 1 CARTONSPRAY15
51672-1396-4Desoximetasone50 mL in 1 BOTTLE, SPRAYSPRAY505
51672-1396-6Desoximetasone50 mL in 1 BOTTLE, SPRAYSPRAY505
51672-1396-6Desoximetasone2 in 1 CARTONSPRAY25
51672-1396-7Desoximetasone1 in 1 CARTONSPRAY15
51672-1396-7Desoximetasone100 mL in 1 BOTTLE, SPRAYSPRAY1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1396-7ML - Milliliter51672-13962c364ead-513c-4bde-8361-f74e8dda652012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1396DESOXIMETASONE SPRAY [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 8 package rows20241222_b046ab97-ba1a-4be6-a238-09670b38b397.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.b046ab97-ba1a-4be6-a238-09670b38b3972025-07-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 204141
application number: NDA204141
ndc (product): 51672-1396
TopicortDESOXIMETASONESun Pharmaceutical Industries, Inc.e417856a-b760-4626-bc34-8e4bc62c026c2025-07-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 204141
application number: NDA204141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1376338desoximetasone 0.25 % Topical SprayPSNb046ab97-ba1a-4be6-a238-09670b38b3975
1376338desoximetasone 2.5 MG/ML Topical SpraySCDb046ab97-ba1a-4be6-a238-09670b38b3975
1376338desoximetasone 0.25 % Topical SpraySYb046ab97-ba1a-4be6-a238-09670b38b3975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1396-3516721396031 BOTTLE, SPRAY in 1 CARTON (51672-1396-3) / 30 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent
51672-1396-4516721396041 BOTTLE, SPRAY in 1 CARTON (51672-1396-4) / 50 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent
51672-1396-6516721396062 BOTTLE, SPRAY in 1 CARTON (51672-1396-6) / 50 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent
51672-1396-7516721396071 BOTTLE, SPRAY in 1 CARTON (51672-1396-7) / 100 mL in 1 BOTTLE, SPRAY2018-07-270000-00-00NoNoCurrent