Triamcinolone Acetonide

Product NDC
68788-8356
11-digit product format
687888356
Labeler code
68788
Product ID
68788-8356_8f6d16ca-4027-4d6c-8d99-98cfbbc56eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040039
Marketing category
ANDA
Marketing start
2023-02-10
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage68788-835668788-8356-8DDiscontinued by firm2026-08-03

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 · 12 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…

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
A040039-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040039-001AT

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 UTC2026-02A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040039-001TRIAMCINOLONE ACETONIDE0.1%CREAM / TOPICALAT1997-11-26cb3db0bc1861…

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 UTC2026-02A040039-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040039-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040039-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040039-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040039-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040039-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040039-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040039-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040039-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040039-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040039-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040039-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040039-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040039-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040039-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040039-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040039-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040039-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040039-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040039-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040039-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040039-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040039-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040039-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040039-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040039-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040039-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040039-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040039-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040039-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040039-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040039-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040039-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040039-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040039-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040039-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040039-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040039-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040039-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040039-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Triamcinolone Acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014314Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99f8a0e6-8ee8-4430-b1d5-1022da1d72abAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8356-0Triamcinolone Acetonide80 g in 1 TUBECREAM806
68788-8356-0Triamcinolone Acetonide1 in 1 CARTONCREAM16
68788-8356-3Triamcinolone Acetonide30 g in 1 TUBECREAM306
68788-8356-8Triamcinolone Acetonide1 in 1 CARTONCREAM16
68788-8356-8Triamcinolone Acetonide30 g in 1 TUBECREAM306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8356-0GM - Gram68788-835638680aa7-151c-4d77-8fbd-eeaf377de43512023-04-07
68788-8356-3GM - Gram68788-8356c66bf2f4-1935-40a6-81a1-86f871418e9112023-03-13
68788-8356-8GM - Gram68788-835649de689f-34b9-4bfa-bbe8-c932245158a012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8356TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS INC.]5Current NDC, 5 package rows20240823_99f8a0e6-8ee8-4430-b1d5-1022da1d72ab.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.e7e16fc2-0222-44f5-925b-928d249f55cf2025-10-15Adverse reactionsExact identifier
application applno (ANDA): 040039
application number: ANDA040039
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.99f8a0e6-8ee8-4430-b1d5-1022da1d72ab2025-10-01Adverse reactionsExact identifier
application applno (ANDA): 040039
application number: ANDA040039
ndc (product): 68788-8356
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.dff0403f-1c0c-3333-e053-2a95a90a4c092024-12-24Adverse reactionsExact identifier
application applno (ANDA): 040039
application number: ANDA040039
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPde5bad69-a014-4e25-b1b9-214373ca57a52024-02-01Adverse reactionsExact identifier
application applno (ANDA): 040039
application number: ANDA040039

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 0.1 % Topical CreamSY99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8356-0687888356001 TUBE in 1 CARTON (68788-8356-0) / 80 g in 1 TUBE1 tube2023-03-14NoNoCurrent
68788-8356-36878883560330 g in 1 TUBE (68788-8356-3) 30 g2023-03-13NoNoCurrent
68788-8356-8687888356081 in 1 CARTONHistorical