Eysuvis

Product NDC
71571-333
11-digit product format
715710333
Labeler code
71571
Product ID
71571-333_db147c65-ed03-4af5-af1f-86b9ff51148a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
ALCON LABORATORIES, INC.
Application
NDA210933
Marketing category
NDA
Marketing start
2020-11-18
Substance
LOTEPREDNOL ETABONATE
Active strength
2.5 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 42.

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
N210933-001EYSUVISLOTEPREDNOL ETABONATE0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210933-001100585112033-05-03U-2492Drug product2020-11-20
N210933-001106464362033-05-03Drug product2020-11-20
N210933-001106880452033-05-03Drug product2020-11-20
N210933-001108570962033-05-03U-29852020-12-28
N210933-001109401082033-05-03U-29852021-03-30
N210933-001109459482033-05-03U-29852021-03-30
N210933-001109939082033-05-03U-31172021-05-26
N210933-001112195962033-05-03U-29852022-01-21
N210933-001115965992033-05-03U-29852023-03-31
N210933-001116423172033-05-03Drug product2023-05-31
N210933-001118723182033-05-03Drug product2024-02-01
N210933-001121152462033-05-03U-2985Drug product2024-11-08
N210933-00190560572033-05-03U-2491Drug product2020-11-20
N210933-00193932132033-05-03Drug product2020-11-20
N210933-00195329552033-05-03U-24912020-11-20
N210933-00197374912033-05-03U-24922020-11-20
N210933-00198271912033-05-03U-2985Drug product2020-11-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-268869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N210933-001EYSUVIS0.25%SUSPENSION/DROPS / OPHTHALMICRLD, RS2020-10-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 14 · 543 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N210933-001100585112033-05-03U-2492Drug product2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001106464362033-05-03Drug product2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001106880452033-05-03Drug product2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001108570962033-05-03U-29852020-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001109401082033-05-03U-29852021-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001109459482033-05-03U-29852021-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001109939082033-05-03U-31172021-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001112195962033-05-03U-29852022-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001115965992033-05-03U-29852023-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001116423172033-05-03Drug product2023-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001118723182033-05-03Drug product2024-02-01caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-001121152462033-05-03U-2985Drug product2024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-00190560572033-05-03U-2491Drug product2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-00193932132033-05-03Drug product2020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-00195329552033-05-03U-24912020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-00197374912033-05-03U-24922020-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07N210933-00198271912033-05-03U-2985Drug product2020-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210933-001100585112033-05-03U-2492Drug product2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001106464362033-05-03Drug product2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001106880452033-05-03Drug product2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001108570962033-05-03U-29852020-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001109401082033-05-03U-29852021-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001109459482033-05-03U-29852021-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001109939082033-05-03U-31172021-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001112195962033-05-03U-29852022-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001115965992033-05-03U-29852023-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001116423172033-05-03Drug product2023-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001118723182033-05-03Drug product2024-02-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-001121152462033-05-03U-2985Drug product2024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-00190560572033-05-03U-2491Drug product2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-00193932132033-05-03Drug product2020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-00195329552033-05-03U-24912020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-00197374912033-05-03U-24922020-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210933-00198271912033-05-03U-2985Drug product2020-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001100585112033-05-03U-2492Drug product2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001106464362033-05-03Drug product2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001106880452033-05-03Drug product2020-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001108570962033-05-03U-29852020-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001109401082033-05-03U-29852021-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210933-001109459482033-05-03U-29852021-03-3031067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210933-001NP2023-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210933-001NP2023-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210933-001NP2023-10-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N210933-001NP2023-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210933-001NP2023-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210933-001NP2023-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N210933-001NP2023-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210933-001NP2023-10-268869cabd3fbd…
2023-12-20 04:57 UTC2023-12N210933-001NP2023-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210933-001NP2023-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210933-001NP2023-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210933-001NP2023-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210933-001NP2023-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N210933-001NP2023-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N210933-001NP2023-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210933-001NP2023-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210933-001NP2023-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210933-001NP2023-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N210933-001NP2023-10-26cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Eysuvis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YEH1EZ96K6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2464838Internal RxNorm lookup
2464843Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2169d82-4275-4ab6-a1c3-c274080b815cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f474382-f6ee-e00d-5df3-bba50cddfd89Product name520251114
64ba4d79-5363-eefc-3390-ee5d2a50a350Product name320250304
100e83dc-ec8c-9e2e-76d2-5112415ec972Product name320241008
4300453c-d545-46d1-b115-18b12b4ccf79Product name120210525
3f316f1c-2561-47c9-9865-ba2be69e0b3eProduct name120190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35Product name120181206
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b5c5cd73-a27b-5e41-bd36-3de9471473cdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71571-333-01Eysuvis1 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS110
71571-333-01Eysuvis1 in 1 CARTONSUSPENSION/ DROPS110
71571-333-24Eysuvis2.4 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS2.410
71571-333-83Eysuvis8.3 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS8.310
71571-333-83Eysuvis1 in 1 CARTONSUSPENSION/ DROPS110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71571-333EYSUVIS (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]10Current NDC, Legacy NDC, 5 package rows20250316_a2169d82-4275-4ab6-a1c3-c274080b815c.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EysuvisLOTEPREDNOL ETABONATEALCON LABORATORIES, INC.a2169d82-4275-4ab6-a1c3-c274080b815c2025-03-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 210933
application number: NDA210933
ndc (product): 71571-333

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2464843EYsuVIS 0.25 % Ophthalmic SuspensionPSNa2169d82-4275-4ab6-a1c3-c274080b815c10
2464838loteprednol etabonate 0.25 % Ophthalmic SuspensionPSNa2169d82-4275-4ab6-a1c3-c274080b815c10
2464843loteprednol etabonate 2.5 MG/ML Ophthalmic Suspension [Eysuvis]SBDa2169d82-4275-4ab6-a1c3-c274080b815c10
2464838loteprednol etabonate 2.5 MG/ML Ophthalmic SuspensionSCDa2169d82-4275-4ab6-a1c3-c274080b815c10
2464843Eysuvis 0.25 % Ophthalmic SuspensionSYa2169d82-4275-4ab6-a1c3-c274080b815c10
2464843Eysuvis 2.5 MG/ML Ophthalmic SuspensionSYa2169d82-4275-4ab6-a1c3-c274080b815c10
2464838loteprednol etabonate 0.25 % Ophthalmic SuspensionSYa2169d82-4275-4ab6-a1c3-c274080b815c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71571-333-01715710333011 BOTTLE, DROPPER in 1 CARTON (71571-333-01) / 1 mL in 1 BOTTLE, DROPPER2023-12-14YesNoCurrent
71571-333-24715710333242.4 mL in 1 BOTTLE, DROPPER (71571-333-24) 2.4 ml2020-11-180000-00-00YesNoCurrent
71571-333-83715710333831 BOTTLE, DROPPER in 1 CARTON (71571-333-83) / 8.3 mL in 1 BOTTLE, DROPPER2020-11-180000-00-00NoNoCurrent