Triamcinolone Acetonide

Product NDC
40032-097
11-digit product format
400320097
Labeler code
40032
Product ID
40032-097_a6ca6e2d-56f8-4af6-967d-598ad727c779
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207365
Marketing category
ANDA
Marketing start
2018-10-12
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct40032-097IInactivated by FDA2026-10-02
excluded packagepackage40032-09740032-097-15IInactivated by FDA2026-10-02
excluded packagepackage40032-09740032-097-80IInactivated by FDA2026-10-02

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 · 45 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 packagepackage40032-097-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage40032-097-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40032-097-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage40032-097-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage40032-097-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage40032-097-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage40032-097-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage40032-097-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage40032-097-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage40032-097-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage40032-097-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage40032-097-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage40032-097-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage40032-097-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage40032-097-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage40032-097-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage40032-097-800efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage40032-097-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage40032-097-80ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage40032-097-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage40032-097-80367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage40032-097-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage40032-097-80557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage40032-097-15557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage40032-097-808af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage40032-097-158af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage40032-097-80834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage40032-097-15834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage40032-097-801332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage40032-097-151332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207365-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207365-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-1284e616aacf4f…
2026-08-18 06:07:402026-07A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-123f01610625f2…
2019-09-15 20:21 UTC2019-09A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207365-001TRIAMCINOLONE ACETONIDE0.1%OINTMENT / TOPICALAT2018-10-12f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207365-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A207365-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207365-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207365-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207365-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207365-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207365-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207365-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207365-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207365-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207365-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207365-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207365-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207365-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207365-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207365-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207365-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207365-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207365-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207365-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207365-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207365-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207365-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A207365-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207365-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207365-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207365-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A207365-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207365-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207365-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207365-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207365-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207365-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207365-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207365-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207365-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207365-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207365-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207365-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207365-001AT1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
40032-097-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT12
40032-097-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT152
40032-097-80Triamcinolone Acetonide80 g in 1 TUBEOINTMENT802
40032-097-80Triamcinolone Acetonide1 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-097TRIAMCINOLONE ACETONIDE OINTMENT [NOVEL LABORATORIES, INC.]2Legacy NDC, 4 package rows20181129_0afbd82a-2453-49fd-adfb-64aaca74a651.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN0afbd82a-2453-49fd-adfb-64aaca74a6512
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD0afbd82a-2453-49fd-adfb-64aaca74a6512
1085636triamcinolone acetonide 0.1 % Topical OintmentSY0afbd82a-2453-49fd-adfb-64aaca74a6512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-097-15400320097151 TUBE in 1 CARTON (40032-097-15) > 15 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent
40032-097-80400320097801 TUBE in 1 CARTON (40032-097-80) > 80 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent