Home NDC 68788-8356 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040039-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040039-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040039-001 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 1997-11-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Triamcinolone Acetonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMCINOLONE ACETONIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F446C597KA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014314 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8356-0 Triamcinolone Acetonide 80 g in 1 TUBE CREAM 80 6 68788-8356-0 Triamcinolone Acetonide 1 in 1 CARTON CREAM 1 6 68788-8356-3 Triamcinolone Acetonide 30 g in 1 TUBE CREAM 30 6 68788-8356-8 Triamcinolone Acetonide 1 in 1 CARTON CREAM 1 6 68788-8356-8 Triamcinolone Acetonide 30 g in 1 TUBE CREAM 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8356 TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS INC.] 5 Current NDC, 5 package rows 20240823_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8356-0 68788835600 1 TUBE in 1 CARTON (68788-8356-0) / 80 g in 1 TUBE 1 tube 2023-03-14 No No Current 68788-8356-3 68788835603 30 g in 1 TUBE (68788-8356-3) 30 g 2023-03-13 No No Current 68788-8356-8 68788835608 1 in 1 CARTON Historical