Triamcinolone Acetonide

Product NDC
52565-014
Requested package NDC
52565-014-80
11-digit product format
525650014
Labeler code
52565
Product ID
52565-014_48fc2abe-dc67-4be0-97df-a2ca347c1efb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA205373
Marketing category
ANDA
Marketing start
2016-05-13
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
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 packagepackage52565-01452565-014-80IInactivated 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
A205373-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205373-001AT

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 UTC2026-02A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133f01610625f2…
2019-09-15 20:21 UTC2019-09A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205373-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2016-05-13cb3db0bc1861…

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 UTC2026-02A205373-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205373-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205373-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205373-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205373-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205373-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205373-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205373-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205373-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205373-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205373-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205373-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205373-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205373-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205373-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205373-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205373-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205373-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205373-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205373-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205373-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A205373-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205373-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205373-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205373-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A205373-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205373-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205373-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205373-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205373-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205373-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205373-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205373-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205373-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A205373-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A205373-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205373-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205373-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205373-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205373-001AT1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-014-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT154
52565-014-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT14
52565-014-26Triamcinolone Acetonide1 in 1 CARTONOINTMENT14
52565-014-26Triamcinolone Acetonide454 g in 1 JAROINTMENT4544
52565-014-80Triamcinolone Acetonide80 g in 1 TUBEOINTMENT804
52565-014-80Triamcinolone Acetonide1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-014-15GM - Gram52565-01422957237-45a9-4de1-953f-d9376b60b34112016-07-19
52565-014-26GM - Gram52565-0147893cd7e-6900-48a2-aad5-69e5f06b1f3712016-07-19
52565-014-80GM - Gram52565-0141892d50b-b513-44b4-ae9f-061fec1cb8ac12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-014TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [TELIGENT PHARMA, INC.]4Legacy NDC, 6 package rows20211030_c25f35ab-c04c-496d-803f-2e497292faf8.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 ACETONIDEEncube Ethicals, Inc.6a31a0c3-2b6e-40e3-b5ea-5c665afd35672026-07-06Adverse reactionsExact identifier
application applno (ANDA): 205373
application number: ANDA205373
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEA-S Medication Solutionsf65c5847-365e-44b0-a756-1b16788684db2025-10-09Adverse reactionsExact identifier
application applno (ANDA): 205373
application number: ANDA205373

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNc25f35ab-c04c-496d-803f-2e497292faf84
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDc25f35ab-c04c-496d-803f-2e497292faf84
1085636triamcinolone acetonide 0.1 % Topical OintmentSYc25f35ab-c04c-496d-803f-2e497292faf84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-014-80525650014801 TUBE in 1 CARTON (52565-014-80) > 80 g in 1 TUBE1 tube2019-09-110000-00-00NoNoCurrent