Home NDC 0065-0543 TRIESENCE
Product NDC 0065-0543
11-digit product format 000650543
Labeler code 0065
Product ID 0065-0543_327d9281-7dab-4282-87c3-3fcc73005a26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triamcinolone acetonide
Dosage form INJECTION, SUSPENSION
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA022048
Marketing category NDA
Marketing start 2007-11-15
Marketing end 0000-00-00
Substance TRIAMCINOLONE ACETONIDE
Active strength 40 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0065-0543-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0065-0543-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0065-0543-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0065-0543-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0065-0543-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0065-0543-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0065-0543-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0065-0543-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0065-0543-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0065-0543-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0065-0543-01 367a005e9d99…383a685ebd0f…
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 N022048-001 TRIESENCE TRIAMCINOLONE ACETONIDE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022048-001 8211880 2029-03-10 U-1257 2012-08-06 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 N022048-001 8128960 2029-12-17 Drug product
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 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022048-001 TRIESENCE 40MG/ML (40MG/ML) INJECTABLE / INTRAVITREAL RLD, RS 2007-11-29 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022048-001 8128960 2029-12-17 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022048-001 8128960 2029-12-17 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022048-001 8128960 2029-12-17 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022048-001 8128960 2029-12-17 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022048-001 8128960 2029-12-17 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022048-001 8128960 2029-12-17 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022048-001 8128960 2029-12-17 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022048-001 8128960 2029-12-17 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022048-001 8128960 2029-12-17 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022048-001 8128960 2029-12-17 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022048-001 8128960 2029-12-17 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022048-001 8128960 2029-12-17 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022048-001 8211880 2029-03-10 U-1257 2012-08-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022048-001 8128960 2029-12-17 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022048-001 8211880 2029-03-10 U-1258 2012-08-06 8072bd15b7f6…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRIAMCINOLONE ACETONIDE ACTIVE INGREDIENT F446C597KA TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 TRIAMCINOLONE ACETONIDE ACTIVE MOIETY F446C597KA TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 CALCIUM CHLORIDE INACTIVE INGREDIENT M4I0D6VV5M TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 MAGNESIUM CHLORIDE INACTIVE INGREDIENT 02F3473H9O TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION [ALCON LABORATORIES, INC.] 6
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0065-0543-01 00065054301 1 BLISTER PACK in 1 CARTON (0065-0543-01) > 1 VIAL, GLASS in 1 BLISTER PACK > 1 mL in 1 VIAL, GLASS 1 blister pack 2007-11-15 0000-00-00 No No Current