Desoximetasone

Product NDC
52565-045
Requested package NDC
52565-045-99
11-digit product format
525650045
Labeler code
52565
Product ID
52565-045_4063b564-73b7-4dde-b477-234aababe830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209973
Marketing category
ANDA
Marketing start
2018-10-23
Marketing end
0000-00-00
Substance
DESOXIMETASONE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage52565-04552565-045-99IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209973-001DESOXIMETASONEDESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209973-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209973-001DESOXIMETASONE0.05%OINTMENT / TOPICALAB2018-10-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209973-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209973-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209973-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209973-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209973-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209973-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209973-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209973-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209973-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209973-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209973-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209973-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209973-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209973-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209973-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209973-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209973-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209973-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209973-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209973-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209973-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209973-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209973-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209973-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209973-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209973-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209973-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209973-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209973-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209973-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209973-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209973-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209973-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209973-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209973-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209973-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209973-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209973-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209973-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209973-001AB1cb3db0bc1861…

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
52565-045-15Desoximetasone1 in 1 CARTONOINTMENT13
52565-045-15Desoximetasone15 g in 1 TUBEOINTMENT153
52565-045-30Desoximetasone1 in 1 CARTONOINTMENT13
52565-045-30Desoximetasone30 g in 1 TUBEOINTMENT303
52565-045-60Desoximetasone1 in 1 CARTONOINTMENT13
52565-045-60Desoximetasone60 g in 1 TUBEOINTMENT603
52565-045-99Desoximetasone100 g in 1 TUBEOINTMENT1003
52565-045-99Desoximetasone1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-045-60GM - Gram52565-0452f878b8b-50a3-4bfe-a332-fb653be99ba212019-04-11
52565-045-99GM - Gram52565-04513fc2ebe-b21a-4152-9560-93e07bb80a6a12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-045DESOXIMETASONE OINTMENT [TELIGENT PHARMA, INC.]3Legacy NDC, 8 package rows20210918_d6431349-3069-47fa-e1f9-79ed132faea7.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
DesoximetasoneDESOXIMETASONEBryant Ranch Prepackfdee36f3-7630-4298-ab7c-f5f8ff7c4c042026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209973
application number: ANDA209973
DesoximetasoneDESOXIMETASONEThe J. Molner Company LLC2bbb5200-8355-ba86-e063-6394a90a23b62025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209973
application number: ANDA209973

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141850desoximetasone 0.05 % Topical OintmentPSNd6431349-3069-47fa-e1f9-79ed132faea73
141850desoximetasone 0.0005 MG/MG Topical OintmentSCDd6431349-3069-47fa-e1f9-79ed132faea73
141850desoximetasone 0.05 % Topical OintmentSYd6431349-3069-47fa-e1f9-79ed132faea73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-045-99525650045991 TUBE in 1 CARTON (52565-045-99) > 100 g in 1 TUBE1 tube2018-10-230000-00-00NoNoCurrent