Home NDC 0713-0228-80 Triamcinolone Acetonide
Product NDC 0713-0228
Requested package NDC 0713-0228-80
11-digit product format 007130228
Labeler code 0713
Product ID 0713-0228_2874a9b6-bcdd-0f7c-e063-6394a90ace1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA089796
Marketing category ANDA
Marketing start 2015-09-10
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 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 A089796-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089796-001 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 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089796-001 TRIAMCINOLONE ACETONIDE 0.1% OINTMENT / TOPICAL AT 1988-12-23 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1085633 Internal RxNorm lookup 1085636 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 0713-0228-15 Triamcinolone Acetonide 1 in 1 CARTON OINTMENT 1 13 0713-0228-15 Triamcinolone Acetonide 15 g in 1 TUBE OINTMENT 15 13 0713-0228-31 Triamcinolone Acetonide 1 in 1 CARTON OINTMENT 1 13 0713-0228-31 Triamcinolone Acetonide 30 g in 1 TUBE OINTMENT 30 13 0713-0228-80 Triamcinolone Acetonide 1 in 1 CARTON OINTMENT 1 13 0713-0228-80 Triamcinolone Acetonide 80 g in 1 TUBE OINTMENT 80 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0228 TRIAMCINOLONE ACETONIDE OINTMENT [COSETTE PHARMACEUTICALS, INC.] 13 Current NDC, Legacy NDC, 6 package rows 20241207_5397395a-2d13-9311-7cb2-c316339d4acc.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.
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 0713-0228-80 00713022880 1 TUBE in 1 CARTON (0713-0228-80) / 80 g in 1 TUBE 1 tube 2015-09-10 0000-00-00 No No Current