Home NDC 17478-209-10 Ketorolac Tromethamine
Product NDC 17478-209
Requested package NDC 17478-209-10
11-digit product format 174780209
Labeler code 17478
Product ID 17478-209_25d16426-8954-4341-96e6-108b1cbac0b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ketorolac tromethamine
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Akorn
Application ANDA078434
Marketing category ANDA
Marketing start 2009-11-05
Marketing end 0000-00-00
Substance KETOROLAC TROMETHAMINE
Active strength 5 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A078434-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05
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 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC 2009-11-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078434-001 KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT 2009-11-05 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 17478-209-10 2024-01-30 C162847 48780-1 1030e365-6d15-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991 17478-209-11 2024-01-30 C162847 48780-1 1030e365-6d15-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991 17478-209-19 2024-01-30 C162847 48780-1 1030e365-6d15-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-209-10 Ketorolac Tromethamine 1 in 1 CARTON SOLUTION 1 6 17478-209-10 Ketorolac Tromethamine 5 mL in 1 BOTTLE, DROPPER SOLUTION 5 6 17478-209-11 Ketorolac Tromethamine 1 in 1 CARTON SOLUTION 1 6 17478-209-11 Ketorolac Tromethamine 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 6 17478-209-19 Ketorolac Tromethamine 3 mL in 1 BOTTLE, DROPPER SOLUTION 3 6 17478-209-19 Ketorolac Tromethamine 1 in 1 CARTON SOLUTION 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ketorolac tromethamine ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 KETOROLAC TROMETHAMINE ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 ketorolac ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 KETOROLAC ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 hydrochloric acid INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 octoxynol-40 INACTIVE INGREDIENT 9T1C662FKS KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 OCTOXYNOL-40 INACTIVE INGREDIENT 9T1C662FKS KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 sodium chloride INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE SOLUTION [STAT RX USA LLC] 2 water INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE SOLUTION [AKORN INC.] 2 ketorolac tromethamine ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 ketorolac ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 octoxynol-40 INACTIVE INGREDIENT 9T1C662FKS KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-209 KETOROLAC TROMETHAMINE SOLUTION [AKORN] 6 Legacy NDC, 6 package rows 20220201_3196b192-439c-4a71-a002-358efdd5b6e6.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 Marketing start Marketing end Sample Exclude flag Status 17478-209-10 17478020910 1 BOTTLE, DROPPER in 1 CARTON (17478-209-10) > 5 mL in 1 BOTTLE, DROPPER 2009-11-05 0000-00-00 No No Current