Home NDC 67857-806-19 Trianex 0.05%
Product NDC 67857-806
Requested package NDC 67857-806-19
11-digit product format 678570806
Labeler code 67857
Product ID 67857-806_c22646b3-ed67-5eb9-e053-2a95a90ab780
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide Ointment
Dosage form OINTMENT
Route TOPICAL
Labeler Promius Pharma, LLC
Application ANDA089595
Marketing category ANDA
Marketing start 2015-02-18
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 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 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089595-001 TRIANEX TRIAMCINOLONE ACETONIDE 0.05% OINTMENT / TOPICAL 1995-03-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL RS 1995-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL RS 1995-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089595-001 TRIAMCINOLONE ACETONIDE IN ABSORBASE 0.05% OINTMENT / TOPICAL RS 1995-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL 1995-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089595-001 TRIANEX 0.05% OINTMENT / TOPICAL AT RS 1995-03-23 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67857-806-19 Trianex 0.05% 430 g in 1 JAR OINTMENT 430 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded triamcinolone acetonide ACTIVE INGREDIENT F446C597KA TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Triamcinolone Acetonide ACTIVE MOIETY F446C597KA TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Ceresin INACTIVE INGREDIENT Q1LS2UJO3A TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Lanolin Alcohols INACTIVE INGREDIENT 884C3FA9HE TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1 Water INACTIVE INGREDIENT 059QF0KO0R TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67857-806 TRIANEX 0.05% (TRIAMCINOLONE ACETONIDE OINTMENT) OINTMENT [PROMIUS PHARMA, LLC] 3 Legacy NDC, 1 package rows 20210513_cde13809-a606-12ca-aece-f2ae594baa71.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67857-806-19 67857080619 430 g in 1 JAR (67857-806-19) 430 g 2015-02-18 0000-00-00 No No Current