Home NDC 62225-600 Omidria
Product NDC 62225-600
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 KETOROLAC; PHENYLEPHRINE
Active strength 2.88; 10.16 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 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 · 51 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62225-600-00 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62225-600-99 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62225-600-04 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62225-600-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62225-600-00 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62225-600-99 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62225-600-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62225-600-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62225-600-00 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62225-600-99 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62225-600-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 62225-600-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62225-600-00 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62225-600-99 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62225-600-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 62225-600-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62225-600-00 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62225-600-99 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62225-600-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 62225-600-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62225-600-00 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62225-600-99 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62225-600-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 62225-600-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62225-600-99 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62225-600-10 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62225-600-04 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 62225-600-00 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62225-600-99 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62225-600-10 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62225-600-04 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 62225-600-00 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62225-600-99 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62225-600-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62225-600-04 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 62225-600-00 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62225-600-99 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 62225-600-10 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62225-600-99 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 62225-600-10 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62225-600-99 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 62225-600-10 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205388-001 OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205388-001 AT
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205388-001 9066856 2033-10-23 Drug product 2015-07-13 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 N205388-001 9066856*PED 2034-04-23 Pediatric extension N205388-001 9486406*PED 2034-04-23 Pediatric 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 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 12 · 446 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9066856*PED 2034-04-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9486406*PED 2034-04-23 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9066856*PED 2034-04-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9486406*PED 2034-04-23 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9066856*PED 2034-04-23 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9486406*PED 2034-04-23 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9066856*PED 2034-04-23 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9486406*PED 2034-04-23 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9066856*PED 2034-04-23 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9486406*PED 2034-04-23 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9066856*PED 2034-04-23 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9486406*PED 2034-04-23 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 8173707*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 8586633*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9278101*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9399040*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9066856*PED 2034-04-23 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9486406*PED 2034-04-23 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205388-001 8173707*PED 2024-01-30 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Omidria
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE 2.88 mg/mL KETOROLAC 10.16 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1WS297W6MV Internal UNII lookup YZI5105V0L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1540230 Internal RxNorm lookup 1540235 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62225-600-00 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 16 62225-600-00 Omidria 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 16 62225-600-04 Omidria 4 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 4 16 62225-600-04 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 16 62225-600-10 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 16 62225-600-10 Omidria 10 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 10 16 62225-600-99 Omidria 4 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 4 16 62225-600-99 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded KETOROLAC ACTIVE INGREDIENT YZI5105V0L OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11 PHENYLEPHRINE ACTIVE INGREDIENT 1WS297W6MV OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11 KETOROLAC ACTIVE MOIETY YZI5105V0L OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11 WATER INACTIVE INGREDIENT 059QF0KO0R OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62225-600 OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION] 15 Current NDC, Legacy NDC, 8 package rows 20221217_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62225-600-00 62225060000 1 VIAL in 1 CARTON (62225-600-00) > 4 mL in 1 VIAL 1 vial 2014-06-13 0000-00-00 No No Current 62225-600-04 62225060004 4 VIAL in 1 CARTON (62225-600-04) > 4 mL in 1 VIAL 4 vial 2014-06-13 0000-00-00 No No Current 62225-600-10 62225060010 10 VIAL in 1 CARTON (62225-600-10) > 4 mL in 1 VIAL 10 vial 2014-06-13 0000-00-00 No No Current 62225-600-99 62225060099 4 VIAL in 1 CARTON (62225-600-99) > 4 mL in 1 VIAL 4 vial 2015-03-17 0000-00-00 No No Current