Home NDC 82604-600 Omidria
Product NDC 82604-600
11-digit product format 826040600
Labeler code 82604
Product ID 82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phenylephrine and ketorolac
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAOCULAR
Labeler Rayner Surgical Inc.
Application NDA205388
Marketing category NDA
Marketing start 2023-07-01
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 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-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 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82604-600-00 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 2 82604-600-00 Omidria 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 2 82604-600-04 Omidria 4 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 4 2 82604-600-04 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 2 82604-600-99 Omidria 4 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 4 2 82604-600-99 Omidria 4 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 4 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82604-600 OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [RAYNER SURGICAL INC.] 2 Current NDC, 6 package rows 20230708_f25d7a42-da2a-7310-e053-2995a90a590f.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 Sample Exclude flag Status 82604-600-00 82604060000 1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL 1 vial 2023-07-01 No No Current 82604-600-04 82604060004 4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL 4 vial 2023-07-01 No No Current 82604-600-99 82604060099 4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL 4 vial 2023-07-01 Yes No Current