Desonide

Product NDC
52565-038
Requested package NDC
52565-038-60
11-digit product format
525650038
Labeler code
52565
Product ID
52565-038_0b2d209c-8b07-4ff6-9180-49f0e83b4443
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA212002
Marketing category
ANDA
Marketing start
2019-03-13
Marketing end
0000-00-00
Substance
DESONIDE
Active strength
1 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52565-03852565-038-60IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-03852565-038-60IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-03852565-038-60IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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
A212002-001DESONIDEDESONIDE0.05%OINTMENT / TOPICAL2019-03-12

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 UTC2026-02A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-123f01610625f2…
2019-09-15 20:21 UTC2019-09A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212002-001DESONIDE0.05%OINTMENT / TOPICALAB2019-03-12cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212002-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212002-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212002-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212002-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212002-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212002-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212002-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212002-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212002-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212002-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212002-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A212002-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A212002-001AB1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212002-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212002-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212002-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212002-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212002-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212002-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212002-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212002-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-038-152023-01-30C16284748780-1f386c649-b25a-0266-e053-dadaa90a7c1aDesonide Ointment, 0.05%
52565-038-602023-01-30C16284748780-1f386c649-b25a-0266-e053-dadaa90a7c1aDesonide Ointment, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-038-15Desonide15 g in 1 TUBEOINTMENT152
52565-038-15Desonide1 in 1 CARTONOINTMENT12
52565-038-60Desonide1 in 1 CARTONOINTMENT12
52565-038-60Desonide60 g in 1 TUBEOINTMENT602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-038-15GM - Gram52565-038054d8040-e6fc-4128-99e4-024ef022e55012019-06-19
52565-038-60GM - Gram52565-038d707fbbb-681d-4f99-9966-850379decec812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-038DESONIDE OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190323_6b2b161f-8ddf-4b16-973f-b32059f9c4d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSN6b2b161f-8ddf-4b16-973f-b32059f9c4d12
204135desonide 0.0005 MG/MG Topical OintmentSCD6b2b161f-8ddf-4b16-973f-b32059f9c4d12
204135desonide 0.05 % Topical OintmentSY6b2b161f-8ddf-4b16-973f-b32059f9c4d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-038-60525650038601 TUBE in 1 CARTON (52565-038-60) > 60 g in 1 TUBE1 tube2019-03-130000-00-00NoNoCurrent