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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022048-001TRIESENCETRIAMCINOLONE ACETONIDE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022048-00182118802029-03-10U-12572012-08-06
N022048-00182118802029-03-10U-12582012-08-06
N022048-00181289602029-12-17Drug 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-293f01610625f2…
2019-09-15 20:21 UTC2019-09N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022048-001TRIESENCE40MG/ML (40MG/ML)INJECTABLE / INTRAVITREALRLD, RS2007-11-29cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022048-00182118802029-03-10U-12582012-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022048-00182118802029-03-10U-12572012-08-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022048-00181289602029-12-17Drug product011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022048-00182118802029-03-10U-12582012-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022048-00182118802029-03-10U-12572012-08-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022048-00181289602029-12-17Drug product31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022048-00182118802029-03-10U-12582012-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022048-00182118802029-03-10U-12572012-08-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022048-00181289602029-12-17Drug product6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022048-00182118802029-03-10U-12582012-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022048-00182118802029-03-10U-12572012-08-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022048-00181289602029-12-17Drug productfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022048-00182118802029-03-10U-12582012-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022048-00182118802029-03-10U-12572012-08-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022048-00181289602029-12-17Drug productb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022048-00182118802029-03-10U-12582012-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022048-00182118802029-03-10U-12572012-08-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022048-00181289602029-12-17Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022048-00182118802029-03-10U-12582012-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022048-00182118802029-03-10U-12572012-08-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022048-00181289602029-12-17Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022048-00182118802029-03-10U-12582012-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022048-00182118802029-03-10U-12572012-08-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022048-00181289602029-12-17Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022048-00182118802029-03-10U-12582012-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022048-00182118802029-03-10U-12572012-08-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022048-00181289602029-12-17Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022048-00182118802029-03-10U-12582012-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N022048-00182118802029-03-10U-12572012-08-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N022048-00181289602029-12-17Drug productd06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022048-00182118802029-03-10U-12582012-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022048-00182118802029-03-10U-12572012-08-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022048-00181289602029-12-17Drug product79d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022048-00182118802029-03-10U-12582012-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022048-00182118802029-03-10U-12572012-08-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022048-00181289602029-12-17Drug product301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022048-00182118802029-03-10U-12582012-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022048-00182118802029-03-10U-12572012-08-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022048-00181289602029-12-17Drug product1e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022048-00182118802029-03-10U-12582012-08-068072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
TRIESENCE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086259Internal RxNorm lookup
1792144Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22692d92-1359-9252-e063-6394a90ab669Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0897-78TRIESENCE1 in 1 BLISTER PACKINJECTION, SUSPENSION12
0078-0897-78TRIESENCE1 in 1 CARTONINJECTION, SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0897-78ML - Milliliter0078-0897a3f6dabe-399d-425c-82e8-b98fd389230612024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0897TRIESENCE (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]1Current NDC, 2 package rows20241001_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIESENCETRIAMCINOLONE ACETONIDEHarrow Eye, LLC2267978c-72ad-9229-e063-6394a90a09d02026-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 022048
application number: NDA022048
TRIESENCETRIAMCINOLONE ACETONIDENovartis Pharmaceuticals Corporation22692d92-1359-9252-e063-6394a90ab6692026-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 022048
application number: NDA022048
ndc (product): 0078-0897

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN22692d92-1359-9252-e063-6394a90ab6692
1086259Triesence 40 MG in 1 ML InjectionPSN22692d92-1359-9252-e063-6394a90ab6692
10862591 ML triamcinolone acetonide 40 MG/ML Injection [Triesence]SBD22692d92-1359-9252-e063-6394a90ab6692
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD22692d92-1359-9252-e063-6394a90ab6692
10862591 ML Triesence 40 MG/ML InjectionSY22692d92-1359-9252-e063-6394a90ab6692
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY22692d92-1359-9252-e063-6394a90ab6692
1086259Triesence 40 MG per 1 ML InjectionSY22692d92-1359-9252-e063-6394a90ab6692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0078-0897-78000780897781 BLISTER PACK in 1 CARTON (0078-0897-78) / 1 VIAL, GLASS in 1 BLISTER PACK / 1 mL in 1 VIAL, GLASS1 blister pack2024-10-01NoNoCurrent