Ketorolac Tromethamine
- Product NDC
- 70518-1159
- 11-digit product format
- 705181159
- Labeler code
- 70518
- Product ID
- 70518-1159_6c4534ec-ecbd-cf9a-e053-2991aa0a0c02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2018-05-07
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-1159 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 70518-1159 | 70518-1159-0 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1159-0 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 70518-1159-0 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204216-001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | |
| A204216-002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204216-001 | AP |
| A204216-002 | AP |
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.
| 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 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204216-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204216-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204216-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204216-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204216-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204216-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204216-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204216-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204216-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204216-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204216-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204216-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204216-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204216-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204216-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204216-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A204216-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204216-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A204216-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A204216-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204216-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A204216-002 | AP | 1 | bb7c543d1eb4… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6a38bd75-79e3-96c0-1204-08a0282902ae | Product name | 4 | 20250128 |
| 4d6e22a5-3693-6edf-0179-2ab93aecbadb | Product name | 9 | 20240724 |
| 03452e68-2506-686e-a908-f2381c778fc6 | Product name | 5 | 20240307 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| bb41bc3a-c643-93c9-055f-a8f48f363af3 | Product name | 2 | 20190219 |
| 4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c | Product name | 1 | 20140508 |
| 8d3e992f-8ff7-c106-f7eb-1e2d5eb12025 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70518-1159-0 | 2025-11-11 | C162847 | 48780-1 | 9d75b9d0-d49e-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Injection, USP |
| 70518-1159-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d49e-f424-e053-dadaa90a57ce | Ketorolac Tromethamine Injection, USP |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1159 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.] | 1 | Legacy NDC | 20180516_cccbc3cc-4df5-4f99-b89e-2915eaef83e7.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 26a1761b-90bf-49c6-9e6a-f293af2296ce | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Direct_rx | 22de8e1c-5e68-fd78-e063-6394a90ad40b | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 43d07956-90ba-4e96-b265-aec03eced19b | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Sportpharm LLC | 2a23b0fa-803c-4abb-b588-12cfe83326a9 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Civica, Inc. | 32198544-4a46-495c-ab65-0836dcbc2c49 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | ProPharma Distribution | 42dfd39e-53a3-e9ee-e063-6394a90ab51e | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 5e42914f-de71-4176-819b-9fa26a8bdce6 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sagent Pharmaceuticals | 62591551-a644-4b2c-a0de-982e906fabc3 | 2025-10-25 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | ProPharma Distribution | 3f2956d9-9e68-f35e-e063-6394a90a706d | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Henry Schein, Inc. | 99c06dde-f218-4d81-91e0-f37a748872d6 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Henry Schein, Inc. | 1e65d11b-5aa9-4a6b-b5d6-c19828748fea | 2025-06-20 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Henry Schein, Inc. | 606b0f2f-de28-42a9-96f4-cacba2c7c56a | 2025-06-19 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 6f727e1f-2838-427b-a236-eeb0101b08f3 | 2024-12-06 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | FOSUN PHARMA USA INC | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 2024-09-20 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Gland Pharma Limited | 5abd4389-4fb2-408b-a27e-cf64b6a921f1 | 2024-09-20 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ada639d4-babb-2ad0-e053-2a95a90afce7 | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | e17f583d-8bd4-3ed0-e053-2a95a90a9090 | 2023-04-25 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | A-S Medication Solutions | b88e562d-226b-4200-afa5-034e628c660f | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac tromethamine | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | ee44c322-4b4b-4397-a1a5-e5b3c3c5a053 | 2022-09-01 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Proficient Rx LP | 014ba8d7-7ed3-4d4a-847a-22b65161117e | 2021-07-01 | Boxed warning, Warnings, Adverse reactions | 204216 ANDA204216 |