Triamcinolone Acetonide

Product NDC
52565-048
11-digit product format
525650048
Labeler code
52565
Product ID
52565-048_a6cb1ad5-f103-47f6-9dea-72b8432ef3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208590
Marketing category
ANDA
Marketing start
2017-03-03
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52565-048IInactivated by FDA2026-08-17
excluded packagepackage52565-04852565-048-15IInactivated 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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52565-048-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52565-048-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52565-048-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-048-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-048-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-048-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-048-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-048-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-048-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-048-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-048-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-048-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-048-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-048-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-048-151332a3947898…d4bfe170f9cd…

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
A208590-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03

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 06:07:402026-07A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-033f01610625f2…
2019-09-15 20:21 UTC2019-09A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICALAT2017-03-03e64feba35796…

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 ZIP2022-06A208590-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208590-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208590-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208590-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208590-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208590-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208590-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A208590-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208590-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208590-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208590-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A208590-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208590-001AT1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208590-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208590-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208590-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208590-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208590-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208590-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208590-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208590-001AT1cb3db0bc1861…

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
52565-048-152023-01-30C16284748780-1f386c64a-1530-0266-e053-dadaa90a7c1aTriamcinolone Acetonide Ointment USP, 0.5% For Dermatologic Use Only Not For Ophthalmic Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-048-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT156
52565-048-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-048-15GM - Gram52565-0481367ab3b-dad9-410e-97bc-63dad379b38712017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-048TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [TELIGENT PHARMA, INC.]6Legacy NDC, 2 package rows20211009_76d9b45a-9efd-efa3-00ad-d32a24ef0ff8.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
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPb05fddfb-7d63-42d8-b41a-003492d3922c2022-09-01Adverse reactionsExact identifier
application applno (ANDA): 208590
application number: ANDA208590
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPe5e3a38d-717d-4412-80d3-7130100add0a2020-09-01Adverse reactionsExact identifier
application applno (ANDA): 208590
application number: ANDA208590

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085640triamcinolone acetonide 0.5 % Topical OintmentPSN76d9b45a-9efd-efa3-00ad-d32a24ef0ff86
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCD76d9b45a-9efd-efa3-00ad-d32a24ef0ff86
1085640triamcinolone acetonide 0.5 % Topical OintmentSY76d9b45a-9efd-efa3-00ad-d32a24ef0ff86
1085640triamcinolone acetonide 0.5 % Topical OintmentPSNe5e3a38d-717d-4412-80d3-7130100add0a4
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCDe5e3a38d-717d-4412-80d3-7130100add0a4
1085640triamcinolone acetonide 0.5 % Topical OintmentSYe5e3a38d-717d-4412-80d3-7130100add0a4
1085640triamcinolone acetonide 0.5 % Topical OintmentPSNcb6c3460-4aaa-487a-97ba-a176af212f951
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCDcb6c3460-4aaa-487a-97ba-a176af212f951
1085640triamcinolone acetonide 0.5 % Topical OintmentSYcb6c3460-4aaa-487a-97ba-a176af212f951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-048-15525650048151 TUBE in 1 CARTON (52565-048-15) > 15 g in 1 TUBE1 tube2017-03-030000-00-00NoNoCurrent