Home NDC 0713-0676-53 Triamcinolone Acetonide
Product NDC 0713-0676
Requested package NDC 0713-0676-53
11-digit product format 007130676
Labeler code 0713
Product ID 0713-0676_eeaf2d1b-9102-e008-e053-2995a90ae1b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamcinolone Acetonide
Dosage form LOTION
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA089129
Marketing category ANDA
Marketing start 2016-09-13
Substance TRIAMCINOLONE ACETONIDE
Active strength 1 mg/mL
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 A089129-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089129-001 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 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089129-001 TRIAMCINOLONE ACETONIDE 0.1% LOTION / TOPICAL AT 1986-08-14 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/mL
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 1085745 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 0713-0676-53 Triamcinolone Acetonide 60 mL in 1 BOTTLE LOTION 60 7 0713-0676-53 Triamcinolone Acetonide 1 in 1 CARTON LOTION 1 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Triamcinolone Acetonide ACTIVE INGREDIENT F446C597KA TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Triamcinolone Acetonide ACTIVE MOIETY F446C597KA TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Sorbitan Monopalmitate INACTIVE INGREDIENT 77K6Z421KU TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) LOTION [G&W LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0676 TRIAMCINOLONE ACETONIDE LOTION [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20221201_b93b6763-446b-3277-497b-2ee50dcef80c.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 0713-0676-53 00713067653 1 BOTTLE in 1 CARTON (0713-0676-53) / 60 mL in 1 BOTTLE 1 bottle 2016-09-13 0000-00-00 No No Current