Home NDC 0078-0897 TRIESENCE
Product NDC 0078-0897
11-digit product format 000780897
Labeler code 0078
Product ID 0078-0897_4e6e468e-47e6-3f48-e063-6294a90a035d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triamcinolone acetonide
Dosage form INJECTION, SUSPENSION
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA022048
Marketing category NDA
Marketing start 2024-10-01
Substance TRIAMCINOLONE ACETONIDE
Active strength 40 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 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…
Additional Listing Data#
Finished product Yes
Brand name base TRIESENCE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMCINOLONE ACETONIDE 40 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086259 Internal RxNorm lookup 1792144 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 0078-0897-78 TRIESENCE 1 in 1 BLISTER PACK INJECTION, SUSPENSION 1 2 0078-0897-78 TRIESENCE 1 in 1 CARTON INJECTION, SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0897 TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 1 Current NDC, 2 package rows 20241001_22692d92-1359-9252-e063-6394a90ab669.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 Sample Exclude flag Status 0078-0897-78 00078089778 1 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS 1 blister pack 2024-10-01 No No Current