Omidria

Product NDC
62225-600
Requested package NDC
62225-600-99
11-digit product format
622250600
Labeler code
62225
Product ID
62225-600_4ef3b158-3042-6a1f-e063-6394a90a807f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine and ketorolac
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAOCULAR
Labeler
Omeros Corporation
Application
NDA205388
Marketing category
NDA
Marketing start
2014-06-13
Substance
PHENYLEPHRINE; KETOROLAC
Active strength
10.16; 2.88 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62225-60062225-600-99DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
N205388-001OMIDRIAKETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDEEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N205388-001AT

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205388-00190668562033-10-23Drug product2015-07-13
N205388-00194864062033-10-23Drug product2016-11-09
N205388-00198552462033-10-23Drug product2018-01-05
N205388-0019066856*PED2034-04-23Pediatric extension
N205388-0019486406*PED2034-04-23Pediatric extension

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 22:38:342026-08N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-3084e616aacf4f…
2026-08-18 06:07:402026-07N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-303f01610625f2…
2019-09-15 20:21 UTC2019-09N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205388-001OMIDRIAEQ 0.3% BASE;EQ 1% BASESOLUTION / IRRIGATIONATRLD, RS2014-05-30f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N205388-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N205388-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205388-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205388-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205388-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205388-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205388-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205388-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205388-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205388-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205388-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205388-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205388-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205388-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205388-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205388-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205388-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205388-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205388-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N205388-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205388-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205388-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205388-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N205388-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N205388-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205388-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205388-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205388-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205388-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205388-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205388-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205388-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N205388-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N205388-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205388-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205388-001AT1f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 12 · 451 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N205388-00190668562033-10-23Drug product2015-07-1384e616aacf4f…
2026-09-14 22:38:342026-08N205388-00194864062033-10-23Drug product2016-11-0984e616aacf4f…
2026-09-14 22:38:342026-08N205388-00198552462033-10-23Drug product2018-01-0584e616aacf4f…
2026-09-14 22:38:342026-08N205388-0019066856*PED2034-04-23Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N205388-0019486406*PED2034-04-23Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N205388-00190668562033-10-23Drug product2015-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07N205388-00194864062033-10-23Drug product2016-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07N205388-00198552462033-10-23Drug product2018-01-05caaa826d4ba7…
2026-08-18 06:07:402026-07N205388-0019066856*PED2034-04-23Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N205388-0019486406*PED2034-04-23Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205388-00190668562033-10-23Drug product2015-07-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205388-00194864062033-10-23Drug product2016-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205388-00198552462033-10-23Drug product2018-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205388-0019066856*PED2034-04-23Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205388-0019486406*PED2034-04-23Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-00190668562033-10-23Drug product2015-07-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-00194864062033-10-23Drug product2016-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-00198552462033-10-23Drug product2018-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-0019066856*PED2034-04-23Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205388-0019486406*PED2034-04-23Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N205388-00190668562033-10-23Drug product2015-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205388-00194864062033-10-23Drug product2016-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205388-00198552462033-10-23Drug product2018-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205388-0019066856*PED2034-04-23Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205388-0019486406*PED2034-04-23Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-00190668562033-10-23Drug product2015-07-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-00194864062033-10-23Drug product2016-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-00198552462033-10-23Drug product2018-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-0019066856*PED2034-04-23Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205388-0019486406*PED2034-04-23Pediatric extensionfd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-00190668562033-10-23Drug product2015-07-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-00194864062033-10-23Drug product2016-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-00198552462033-10-23Drug product2018-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-0019066856*PED2034-04-23Pediatric extensionb8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205388-0019486406*PED2034-04-23Pediatric extensionb8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-0018173707*PED2024-01-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-0018586633*PED2024-01-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-0019278101*PED2024-01-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-0019399040*PED2024-01-30Pediatric extension03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205388-00190668562033-10-23Drug product2015-07-1303ed91905a0d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205388-001NPP2020-12-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205388-001PED2021-06-0874a2ff9319b5…
2021-12-28 21:50 UTC2021-12N205388-001PED2021-06-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205388-001PED2021-06-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N205388-001PED2021-06-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205388-001NPP2020-12-088869cabd3fbd…
2020-12-22 03:56 UTC2020-12N205388-001PED2021-06-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205388-001NPP2020-12-08c0c555d07b60…
2020-11-12 02:37 UTC2020-11N205388-001PED2021-06-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205388-001NPP2020-12-083f01610625f2…
2019-12-14 00:12 UTC2019-12N205388-001PED2021-06-083f01610625f2…
2019-09-15 20:21 UTC2019-09N205388-001NPP2020-12-08b00525d2431f…
2019-09-15 20:21 UTC2019-09N205388-001PED2021-06-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N205388-001NPP2020-12-08ea99ee380514…
2019-07-19 19:46 UTC2019-07N205388-001PED2021-06-08ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE10.16 mg/mL
KETOROLAC2.88 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1WS297W6MVInternal UNII lookup
YZI5105V0LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1540230Internal RxNorm lookup
1540235Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
21470688-4e81-4ea5-ac38-f72e10552e7eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62225-600-00Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416
62225-600-00Omidria1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE116
62225-600-04Omidria4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE416
62225-600-04Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416
62225-600-10Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416
62225-600-10Omidria10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1016
62225-600-99Omidria4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE416
62225-600-99Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62225-600-00ML - Milliliter62225-60037819fd5-b099-4bab-a80e-42fb4f84e3bb12015-04-03
62225-600-04ML - Milliliter62225-600001bddf6-52b1-4c56-b56a-330a903a866612015-04-03
62225-600-10ML - Milliliter62225-600bc2c4826-054a-4e8b-855a-c907258aedb712015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62225-600OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]15Current NDC, Legacy NDC, 8 package rows20221217_21470688-4e81-4ea5-ac38-f72e10552e7e.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
OmidriaPHENYLEPHRINE AND KETOROLACOmeros Corporation21470688-4e81-4ea5-ac38-f72e10552e7e2026-04-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 205388
application number: NDA205388
ndc (package): 62225-600-99
ndc (product): 62225-600
ndc11 (package): 62225060099
OmidriaPHENYLEPHRINE AND KETOROLACRayner Surgical Inc.f25d7a42-da2a-7310-e053-2995a90a590f2023-07-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 205388
application number: NDA205388

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1540235OMIDRIA 1 % / 0.3 % Concentrate for Ophthalmic Irrigation SolutionPSN21470688-4e81-4ea5-ac38-f72e10552e7e16
1540230phenylephrine 1 % / ketorolac 0.3 % Concentrate for Ophthalmic Irrigation SolutionPSN21470688-4e81-4ea5-ac38-f72e10552e7e16
1540235ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]SBD21470688-4e81-4ea5-ac38-f72e10552e7e16
1540230ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation SolutionSCD21470688-4e81-4ea5-ac38-f72e10552e7e16
1540230ketorolac 0.3 % / phenylephrine 1 % Concentrate for Ophthalmic Irrigation SolutionSY21470688-4e81-4ea5-ac38-f72e10552e7e16
1540235Omidria (ketorolac 0.3 % / phenylephrine 1 % ) Concentrate for Ophthalmic Irrigation SolutionSY21470688-4e81-4ea5-ac38-f72e10552e7e16
1540235Omidria (ketorolac tromethamine 4.24 mg/ml (ketorolac 2.88 MG/ML)) / phenylephrine HCl 12.4 mg/ml (phenylephrine 10.16 MG/ML) Concentrate for Ophthalmic Irrigation SolutionSY21470688-4e81-4ea5-ac38-f72e10552e7e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62225-600-99622250600994 VIAL in 1 CARTON (62225-600-99) > 4 mL in 1 VIAL4 vial2015-03-170000-00-00NoNoCurrent