ketorolac tromethamine
- Product NDC
- 72266-118
- 11-digit product format
- 722660118
- Labeler code
- 72266
- Product ID
- 72266-118_228ec94a-f777-f61b-e063-6394a90a21a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- FOSUN PHARMA USA INC
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2023-06-23
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 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
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-001 | KETOROLAC TROMETHAMINE | 15MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-002 | KETOROLAC TROMETHAMINE | 30MG/ML | INJECTABLE / INJECTION | AP | 2016-11-01 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A204216-002 | AP | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ketorolac tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| KETOROLAC TROMETHAMINE | 30 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4EVE5946BQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72266-118-01 | ketorolac tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | 16 | |
| 72266-118-25 | ketorolac tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 16 | |
| 72266-118-01 | Ketorocaine LM Kit | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 mL | 30 mg in 1mL | 14 |
| 72266-118-01 | Ketorocaine L Kit | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 mL | 30 mg in 1mL | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72266-118-01 | ML - Milliliter | 72266-118 | b2a7bfcf-b1bf-4514-b840-76b801c18c59 | 1 | 2019-06-19 |
| 72266-118-25 | ML - Milliliter | 72266-118 | 016fbe57-69a2-4dcf-8311-ec37db36efb3 | 1 | 2019-06-19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72266-118 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FOSUN PHARMA USA INC] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250306_1aae6a4d-0909-4672-aa26-e3f2d8c4d413.zip |
| 72266-118 | KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC, Legacy NDC | 20241008_35ffe071-8bc1-4c88-8c85-645847acf169.zip |
| 72266-118 | KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 10 | Current NDC, Legacy NDC | 20241008_ee0d396c-5caa-4a1a-9865-1a742d9d8d68.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 72266-118 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | 1aae6a4d-0909-4672-aa26-e3f2d8c4d413 | 16 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | lidocaine HCl 1 % in 2 ML Injection | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | 2 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | lidocaine HCl 1 % per 2 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1737568 | lidocaine HCl 20 MG per 2 ML Injection | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 35ffe071-8bc1-4c88-8c85-645847acf169 | 14 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 43d07956-90ba-4e96-b265-aec03eced19b | 13 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 5e42914f-de71-4176-819b-9fa26a8bdce6 | 13 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 5e42914f-de71-4176-819b-9fa26a8bdce6 | 13 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 43d07956-90ba-4e96-b265-aec03eced19b | 13 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 5e42914f-de71-4176-819b-9fa26a8bdce6 | 13 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 43d07956-90ba-4e96-b265-aec03eced19b | 13 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1737568 | lidocaine HCl 1 % in 2 ML Injection | PSN | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1737568 | 2 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1737568 | lidocaine HCl 1 % per 2 ML Injection | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1737568 | lidocaine HCl 20 MG per 2 ML Injection | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | ee0d396c-5caa-4a1a-9865-1a742d9d8d68 | 11 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 99c06dde-f218-4d81-91e0-f37a748872d6 | 3 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 99c06dde-f218-4d81-91e0-f37a748872d6 | 3 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 99c06dde-f218-4d81-91e0-f37a748872d6 | 3 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | ada639d4-babb-2ad0-e053-2a95a90afce7 | 2 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | ada639d4-babb-2ad0-e053-2a95a90afce7 | 2 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | ada639d4-babb-2ad0-e053-2a95a90afce7 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72266-118-01 | 72266011801 | 1 mL in 1 VIAL | 1 ml | Historical | ||||
| 72266-118-25 | 72266011825 | 25 VIAL in 1 CARTON (72266-118-25) / 1 mL in 1 VIAL (72266-118-01) | 25 vial | 2023-06-23 | 0000-00-00 | No | No | Current |