Triamcinolone Acetonide

Product NDC
52565-010
Requested package NDC
52565-010-59
11-digit product format
525650010
Labeler code
52565
Product ID
52565-010_53e17bda-5532-4bb9-b2a3-1c6c50e2f7f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
LOTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA204608
Marketing category
ANDA
Marketing start
2016-07-08
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
0 mg/mL
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 packagepackage52565-01052565-010-59IInactivated 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
A204608-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07

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 · 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 UTC2026-02A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073f01610625f2…
2019-09-15 20:21 UTC2019-09A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICAL2016-07-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204608-001TRIAMCINOLONE ACETONIDE0.025%LOTION / TOPICALAT2016-07-07cb3db0bc1861…

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 ZIP2022-06A204608-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204608-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204608-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204608-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204608-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204608-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204608-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A204608-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204608-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204608-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204608-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A204608-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204608-001AT1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204608-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204608-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204608-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204608-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204608-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204608-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204608-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204608-001AT1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-010-592023-01-30C16284748780-1f386c64a-2b28-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE LOTION USP, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-010-59Triamcinolone Acetonide1 in 1 CARTONLOTION15
52565-010-59Triamcinolone Acetonide60 mL in 1 BOTTLELOTION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-010-59ML - Milliliter52565-01060cea29c-434c-4035-9e4c-69187c3eb46112016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-010TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [TELIGENT PHARMA, INC.]5Legacy NDC, 2 package rows20211003_27d39f64-ee15-4beb-bbd0-31f8c42ca5e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085741triamcinolone acetonide 0.025 % Topical LotionPSN27d39f64-ee15-4beb-bbd0-31f8c42ca5e05
1085741triamcinolone acetonide 0.25 MG/ML Topical LotionSCD27d39f64-ee15-4beb-bbd0-31f8c42ca5e05
1085741triamcinolone acetonide 0.025 % Topical LotionSY27d39f64-ee15-4beb-bbd0-31f8c42ca5e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-010-59525650010591 BOTTLE in 1 CARTON (52565-010-59) > 60 mL in 1 BOTTLE1 bottle2016-07-080000-00-00NoNoCurrent