Home NDC 65862-775 Ketorolac Tromethamine
Product NDC 65862-775
11-digit product format 658620775
Labeler code 65862
Product ID 65862-775_ffe3b63b-abfc-455b-bc6c-49cd58e406e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Aurobindo Pharma Limited
Application ANDA205191
Marketing category ANDA
Marketing start 2018-11-15
Substance KETOROLAC TROMETHAMINE
Active strength 4 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [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 43 .
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 A205191-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205191-001 KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC 2018-11-15 f41ea6bd6efb…
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 Ketorolac Tromethamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4EVE5946BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860103 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 65862-775-05 Ketorolac Tromethamine 1 in 1 CARTON SOLUTION/ DROPS 1 6 65862-775-05 Ketorolac Tromethamine 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-775 KETOROLAC TROMETHAMINE SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20240830_e93f6501-827d-474c-b660-765b7c0fb871.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.
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 65862-775-05 65862077505 1 BOTTLE in 1 CARTON (65862-775-05) / 5 mL in 1 BOTTLE 1 bottle 2018-11-15 0000-00-00 No No Current