Rhopressa

Product NDC
70727-497
11-digit product format
707270497
Labeler code
70727
Product ID
70727-497_82acde68-4935-4dc9-82ff-9ff7f449f893
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
netarsudil
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC; TOPICAL
Labeler
Alcon Laboratories, Inc.
Application
NDA208254
Marketing category
NDA
Marketing start
2017-12-18
Substance
NETARSUDIL MESYLATE
Active strength
.2 mg/mL
Pharmacologic classes
Rho Kinase Inhibitor [EPC], Rho Kinase Inhibitors [MoA]
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 43.

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
N208254-001RHOPRESSANETARSUDIL MESYLATEEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208254-001105329932026-07-11U-15242020-03-30
N208254-001108828402026-07-11U-15242021-01-22
N208254-001110214562026-07-11U-15242021-06-28
N208254-00184503442026-07-11U-1524Drug substance, Drug product2017-12-21
N208254-00190965692026-07-11U-1524Drug substance, Drug product2017-12-21
N208254-001101740172030-01-27U-1524Drug substance, Drug product2019-03-28
N208254-001106548442030-01-27U-1524Drug substance, Drug product2020-06-10
N208254-001110280812030-01-27U-15242021-06-28
N208254-001116187482030-01-27U-15242023-04-21
N208254-00183948262030-11-10U-1524Drug substance, Drug product2017-12-21
N208254-001105889012034-03-14U-1524Drug substance, Drug product2020-04-15
N208254-001110203852034-03-14U-15242024-07-12
N208254-001111855382034-03-14Drug product2021-12-16
N208254-00194150432034-03-14Drug substance2017-12-21
N208254-00199313362034-03-14U-1524Drug substance, Drug product2018-04-11

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208254-001RHOPRESSAEQ 0.02% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2017-12-18f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 14 · 554 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208254-001105329932026-07-11U-15242020-03-3084e616aacf4f…
2026-09-14 22:38:342026-08N208254-001108828402026-07-11U-15242021-01-2284e616aacf4f…
2026-09-14 22:38:342026-08N208254-001110214562026-07-11U-15242021-06-2884e616aacf4f…
2026-09-14 22:38:342026-08N208254-00184503442026-07-11U-1524Drug substance, Drug product2017-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N208254-00190965692026-07-11U-1524Drug substance, Drug product2017-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N208254-001101740172030-01-27U-1524Drug substance, Drug product2019-03-2884e616aacf4f…
2026-09-14 22:38:342026-08N208254-001106548442030-01-27U-1524Drug substance, Drug product2020-06-1084e616aacf4f…
2026-09-14 22:38:342026-08N208254-001110280812030-01-27U-15242021-06-2884e616aacf4f…
2026-09-14 22:38:342026-08N208254-001116187482030-01-27U-15242023-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N208254-00183948262030-11-10U-1524Drug substance, Drug product2017-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N208254-001105889012034-03-14U-1524Drug substance, Drug product2020-04-1584e616aacf4f…
2026-09-14 22:38:342026-08N208254-001110203852034-03-14U-15242024-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N208254-001111855382034-03-14Drug product2021-12-1684e616aacf4f…
2026-09-14 22:38:342026-08N208254-00194150432034-03-14Drug substance2017-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N208254-00199313362034-03-14U-1524Drug substance, Drug product2018-04-1184e616aacf4f…
2026-08-18 06:07:402026-07N208254-001105329932026-07-11U-15242020-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001108828402026-07-11U-15242021-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001110214562026-07-11U-15242021-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-00184503442026-07-11U-1524Drug substance, Drug product2017-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-00190965692026-07-11U-1524Drug substance, Drug product2017-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001101740172030-01-27U-1524Drug substance, Drug product2019-03-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001106548442030-01-27U-1524Drug substance, Drug product2020-06-10caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001110280812030-01-27U-15242021-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001116187482030-01-27U-15242023-04-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-00183948262030-11-10U-1524Drug substance, Drug product2017-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001105889012034-03-14U-1524Drug substance, Drug product2020-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001110203852034-03-14U-15242024-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-001111855382034-03-14Drug product2021-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-00194150432034-03-14Drug substance2017-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N208254-00199313362034-03-14U-1524Drug substance, Drug product2018-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208254-001105329932026-07-11U-15242020-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-001108828402026-07-11U-15242021-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-001110214562026-07-11U-15242021-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-00184503442026-07-11U-1524Drug substance, Drug product2017-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-00190965692026-07-11U-1524Drug substance, Drug product2017-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-001101740172030-01-27U-1524Drug substance, Drug product2019-03-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-001106548442030-01-27U-1524Drug substance, Drug product2020-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-001110280812030-01-27U-15242021-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-001116187482030-01-27U-15242023-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208254-00183948262030-11-10U-1524Drug substance, Drug product2017-12-21011fe1cb6892…

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 ZIP2022-06N208254-001NCE2022-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208254-001NCE2022-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208254-001NCE2022-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208254-001NCE2022-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208254-001NCE2022-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208254-001NCE2022-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208254-001NCE2022-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N208254-001NCE2022-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208254-001NCE2022-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208254-001NCE2022-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208254-001NCE2022-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09N208254-001NCE2022-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N208254-001NCE2022-12-18ea99ee380514…
2023-01-26 05:58 UTC2023-01N208254-001NCE2022-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208254-001NCE2022-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208254-001NCE2022-12-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208254-001NCE2022-12-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208254-001NCE2022-12-18cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NETARSUDIL MESYLATE.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VL756B1K0UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1992868Internal RxNorm lookup
1992873Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d4f0e3a-5b86-4c43-982a-813b22ae7e22Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
203382e3-d801-4f70-866f-ebe316583560Product name120190624
dc99c89e-d489-4ded-8898-111a91f10877Product name120180221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70727-497-25Rhopressa1 in 1 CARTONSOLUTION/ DROPS117
70727-497-25Rhopressa2.5 mL in 1 BOTTLESOLUTION/ DROPS2.517
70727-497-99Rhopressa1 in 1 CARTONSOLUTION/ DROPS117
70727-497-99Rhopressa2.5 mL in 1 BOTTLESOLUTION/ DROPS2.517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70727-497-25ML - Milliliter70727-4974820c538-7f5c-4eaf-9ba9-795606dad8ff12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70727-497RHOPRESSA (NETARSUDIL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]14Current NDC, Legacy NDC, 4 package rows20240926_7d4f0e3a-5b86-4c43-982a-813b22ae7e22.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
RhopressaNETARSUDILAlcon Laboratories, Inc.7d4f0e3a-5b86-4c43-982a-813b22ae7e222026-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 208254
application number: NDA208254
ndc (product): 70727-497

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1992868netarsudil 0.02 % Ophthalmic SolutionPSN7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.02 % Ophthalmic SolutionPSN7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873netarsudil 0.2 MG/ML Ophthalmic Solution [Rhopressa]SBD7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992868netarsudil 0.2 MG/ML Ophthalmic SolutionSCD7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992868netarsudil 0.02 % Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992868netarsudil 0.2 MG/ML (as netarsudil dimesylate 0.28 MG/ML) Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.02 % Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.2 MG/ML (as netarsudil dimesylate 0.28 MG/ML) Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217
1992873Rhopressa 0.2 MG/ML Ophthalmic SolutionSY7d4f0e3a-5b86-4c43-982a-813b22ae7e2217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70727-497-25707270497251 BOTTLE in 1 CARTON (70727-497-25) / 2.5 mL in 1 BOTTLE1 bottle2017-12-180000-00-00NoNoCurrent
70727-497-99707270497991 BOTTLE in 1 CARTON (70727-497-99) / 2.5 mL in 1 BOTTLE1 bottle2017-12-180000-00-00YesNoCurrent