Topicort

Product NDC
51672-5203
Requested package NDC
51672-5203-1
11-digit product format
516725203
Labeler code
51672
Product ID
51672-5203_f42ec0f5-b9db-4cc1-b466-4ff4869d8a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA074286
Marketing category
ANDA
Marketing start
1992-12-15
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51672-520351672-5203-1IInactivated 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51672-520351672-5203-1IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-520351672-5203-1IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A074286-001TOPICORTDESOXIMETASONE0.25%OINTMENT / TOPICAL1996-06-07

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 06:07:402026-07A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A074286-001TOPICORT0.25%OINTMENT / TOPICALABRS1996-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074286-001TOPICORT0.25%OINTMENT / TOPICAL1996-06-07e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074286-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074286-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074286-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074286-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074286-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074286-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074286-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074286-001AB1ea99ee380514…

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
51672-5203-1Topicort15 g in 1 TUBEOINTMENT155
51672-5203-1Topicort1 in 1 CARTONOINTMENT15
51672-5203-3Topicort60 g in 1 TUBEOINTMENT605
51672-5203-3Topicort1 in 1 CARTONOINTMENT15
51672-5203-5Topicort5 g in 1 TUBEOINTMENT55
51672-5203-7Topicort1 in 1 CARTONOINTMENT15
51672-5203-7Topicort100 g in 1 TUBEOINTMENT1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5203-1GM - Gram51672-5203aafe18e5-410d-410f-8d09-57715d0e08c912012-07-24
51672-5203-3GM - Gram51672-5203a51347b4-8b17-4fb9-95dd-199bd9f8a20412012-07-24
51672-5203-7GM - Gram51672-520385a5781f-7997-461f-92af-da9c4ab17d5012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5203TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Legacy NDC, 7 package rows20190308_612e53ec-720c-47ba-97bc-5db85064e33b.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
DesoximetasoneDESOXIMETASONESun Pharmaceutical Industries, Inc.627031fc-9b91-4854-b08f-f9fc0c73f1de2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074286
application number: ANDA074286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197575desoximetasone 0.25 % Topical OintmentPSN612e53ec-720c-47ba-97bc-5db85064e33b5
94348Topicort 0.25 % Topical OintmentPSN612e53ec-720c-47ba-97bc-5db85064e33b5
94348desoximetasone 0.0025 MG/MG Topical Ointment [Topicort]SBD612e53ec-720c-47ba-97bc-5db85064e33b5
197575desoximetasone 0.0025 MG/MG Topical OintmentSCD612e53ec-720c-47ba-97bc-5db85064e33b5
197575desoximetasone 0.25 % Topical OintmentSY612e53ec-720c-47ba-97bc-5db85064e33b5
94348Topicort 0.0025 MG/MG Topical OintmentSY612e53ec-720c-47ba-97bc-5db85064e33b5
94348Topicort 0.25 % Topical OintmentSY612e53ec-720c-47ba-97bc-5db85064e33b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5203-1516725203011 TUBE in 1 CARTON (51672-5203-1) > 15 g in 1 TUBE1 tube1992-12-150000-00-00NoNoCurrent