Inveltys

Product NDC
0065-9307
11-digit product format
000659307
Labeler code
0065
Product ID
0065-9307_02b53b1c-e4e2-40eb-9283-073996bbee67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol Etabonate
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA210565
Marketing category
NDA
Marketing start
2026-04-16
Marketing end
2026-09-30
Substance
LOTEPREDNOL ETABONATE
Active strength
10 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 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
N210565-001INVELTYSLOTEPREDNOL ETABONATE1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210565-001100585112033-05-03U-2492Drug product2018-09-10
N210565-001106464372033-05-03Drug product2020-06-11
N210565-001106880452033-05-03Drug product2020-07-16
N210565-001108642192033-05-03U-30112020-12-28
N210565-001112195972033-05-03U-32782022-01-21
N210565-001112195972033-05-03U-32792022-01-21
N210565-001116423172033-05-03Drug product2023-05-31
N210565-001118723182033-05-03Drug product2024-02-01
N210565-001121152462033-05-03U-4025Drug product2024-11-08
N210565-00190560572033-05-03U-2491Drug product2018-09-10
N210565-00193932132033-05-03Drug product2018-09-10
N210565-00195329552033-05-03U-24912018-09-10
N210565-00197374912033-05-03U-24922018-09-10
N210565-00198271912033-05-03U-2493Drug product2018-09-10

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-223f01610625f2…
2019-09-15 20:21 UTC2019-09N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N210565-001INVELTYS1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2018-08-22e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 12 · 480 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N210565-001100585112033-05-03U-2492Drug product2018-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001106464372033-05-03Drug product2020-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001106880452033-05-03Drug product2020-07-16caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001108642192033-05-03U-30112020-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001112195972033-05-03U-32782022-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001112195972033-05-03U-32792022-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001116423172033-05-03Drug product2023-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001118723182033-05-03Drug product2024-02-01caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-001121152462033-05-03U-4025Drug product2024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-00190560572033-05-03U-2491Drug product2018-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-00193932132033-05-03Drug product2018-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-00195329552033-05-03U-24912018-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-00197374912033-05-03U-24922018-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N210565-00198271912033-05-03U-2493Drug product2018-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N210565-001100585112033-05-03U-2492Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001106464372033-05-03Drug product2020-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001106880452033-05-03Drug product2020-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001108642192033-05-03U-30112020-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001112195972033-05-03U-32782022-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001112195972033-05-03U-32792022-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001116423172033-05-03Drug product2023-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001118723182033-05-03Drug product2024-02-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-001121152462033-05-03U-4025Drug product2024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-00190560572033-05-03U-2491Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-00193932132033-05-03Drug product2018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-00195329552033-05-03U-24912018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-00197374912033-05-03U-24922018-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210565-00198271912033-05-03U-2493Drug product2018-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001100585112033-05-03U-2492Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001106464372033-05-03Drug product2020-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001106880452033-05-03Drug product2020-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001108642192033-05-03U-30112020-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001112195972033-05-03U-32782022-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001112195972033-05-03U-32792022-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001116423172033-05-03Drug product2023-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001118723182033-05-03Drug product2024-02-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-001121152462033-05-03U-4025Drug product2024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-00190560572033-05-03U-2491Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-00193932132033-05-03Drug product2018-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210565-00195329552033-05-03U-24912018-09-1031067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N210565-001NP2021-08-2274a2ff9319b5…
2021-12-28 21:50 UTC2021-12N210565-001NP2021-08-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N210565-001NP2021-08-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N210565-001NP2021-08-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N210565-001NP2021-08-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N210565-001NP2021-08-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N210565-001NP2021-08-223f01610625f2…
2019-09-15 20:21 UTC2019-09N210565-001NP2021-08-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N210565-001NP2021-08-22ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Inveltys

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE10 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
2055281Internal RxNorm lookup
2055286Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bdd18e84-79b3-4c8b-a07f-eb06cf52e68cAvailable 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
0065-9307-04Inveltys1 in 1 CARTONSUSPENSION11
0065-9307-04Inveltys2.8 mL in 1 BOTTLE, DROPPERSUSPENSION2.81
0065-9307-05Inveltys2.8 mL in 1 BOTTLE, DROPPERSUSPENSION2.81
0065-9307-05Inveltys1 in 1 CARTONSUSPENSION11

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
InveltysLOTEPREDNOL ETABONATEAlcon Laboratories, Inc.bdd18e84-79b3-4c8b-a07f-eb06cf52e68c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 210565
application number: NDA210565
ndc (product): 0065-9307
InveltysLOTEPREDNOL ETABONATEALCON LABORATORIES, INC.2ec16df8-2e5c-4e06-8d28-21df76f27d722026-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 210565
application number: NDA210565

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055286INVELTYS 1 % Ophthalmic SuspensionPSNbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055281loteprednol etabonate 1 % Ophthalmic SuspensionPSNbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055286loteprednol etabonate 10 MG/ML Ophthalmic Suspension [Inveltys]SBDbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055281loteprednol etabonate 10 MG/ML Ophthalmic SuspensionSCDbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055286Inveltys 1 % Ophthalmic SuspensionSYbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055286Inveltys 10 MG/ML Ophthalmic SuspensionSYbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055281loteprednol etabonate 1 % Ophthalmic SuspensionSYbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-9307-04000659307041 BOTTLE, DROPPER in 1 CARTON (0065-9307-04) / 2.8 mL in 1 BOTTLE, DROPPER2026-04-162026-09-30NoNoHistorical
0065-9307-05000659307051 BOTTLE, DROPPER in 1 CARTON (0065-9307-05) / 2.8 mL in 1 BOTTLE, DROPPER2026-04-162026-09-30YesNoHistorical