Home NDC 63629-2488-1 Ketorolac Tromethamine
Product NDC 63629-2488
Requested package NDC 63629-2488-1
11-digit product format 636292488
Labeler code 63629
Product ID 63629-2488_f0564b7b-a2ff-4ae4-9777-8023f11383d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA210616
Marketing category ANDA
Marketing start 2018-10-11
Marketing end 2024-09-30
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 0000-00-00
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 · 11 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…
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.
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 63629-2488-1 63629248801 100 TABLET, FILM COATED in 1 BOTTLE (63629-2488-1) 2022-06-24 2024-09-30 No No Current