Home NDC 52584-084-01 KETOROLAC TROMETHAMINE
Product NDC 52584-084
Requested package NDC 52584-084-01
11-digit product format 525840084
Labeler code 52584
Product ID 52584-084_bbe25685-e4c3-43ab-9165-aa7d447f1f42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name KETOROLAC TROMETHAMINE
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler General Injectables and Vaccines, Inc.
Application ANDA075772
Marketing category ANDA
Marketing start 2018-11-13
Marketing end 0000-00-00
Substance KETOROLAC TROMETHAMINE
Active strength 15 mg/mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 12 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075772-001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 A075772-002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075772-001 KETOROLAC TROMETHAMINE 15MG/ML INJECTABLE / INJECTION AP 2004-07-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075772-002 KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE / INJECTION AP 2004-07-21 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 Units Marketing start Marketing end Sample Exclude flag Status 52584-084-01 52584008401 1 VIAL in 1 BAG (52584-084-01) > 1 mL in 1 VIAL 1 vial 2018-11-13 0000-00-00 No No Current