Home NDC 50090-6265-0 Ketorolac Tromethamine
Product NDC 50090-6265
Requested package NDC 50090-6265-0
11-digit product format 500906265
Labeler code 50090
Product ID 50090-6265_2f815b5d-6289-4ae2-9bea-233f88fd4a7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA210616
Marketing category ANDA
Marketing start 2022-04-15
Marketing end 0000-00-00
Substance KETOROLAC TROMETHAMINE
Active strength 10 mg/1
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 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 A210616-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210616-001 AB
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 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210616-001 KETOROLAC TROMETHAMINE 10MG TABLET / ORAL AB 2018-08-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6265 KETOROLAC TROMETHAMINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 3 Legacy NDC 20231101_de9f7f14-b912-45e6-aebb-61852c53ae58.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-6265-0 50090626500 20 TABLET, FILM COATED in 1 BOTTLE (50090-6265-0) 2022-12-12 0000-00-00 No No Current