NDC 80425-0139-02 - Ketorolac Tromethamine
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0139
- Requested NDC
- 80425-0139-02
- Package NDCs from labels
- 80425-0139-1, 80425-0139-3, 80425-0139-2, 80425-0139-02
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Ketorolac Tromethamine - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0139-1 | Ketorolac Tromethamine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 | |
| 80425-0139-2 | Ketorolac Tromethamine | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | 5 | |
| 80425-0139-3 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0139 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250101_c1717245-cef3-b3d7-e053-2a95a90a1ac5.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0139-1 | EA - Each | 80425-0139 | 70add81b-d8f5-4118-b5c1-05bf84165ade | 1 | 2023-06-06 |
| 80425-0139-2 | EA - Each | 80425-0139 | 0b665173-2504-4c55-b5a5-980fa83937b7 | 1 | 2023-06-06 |
| 80425-0139-3 | EA - Each | 80425-0139 | fcf73ba8-2e41-4714-89c3-f0dc2d794b1e | 1 | 2023-06-06 |
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 | Sportpharm LLC | 2a23b0fa-803c-4abb-b588-12cfe83326a9 | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 6f727e1f-2838-427b-a236-eeb0101b08f3 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | cdd4d548-33f8-42d6-8eae-e36aa577c050 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 04d5114e-332b-4ed0-85df-b276c1dc296c | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | 6758cb38-dec8-468f-94e2-613772e39b9a | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Redpharm Drug | 59d86768-6214-8389-e063-6394a90a0a3d | 2026-08-25 | Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | 54dec321-b4c9-f0d6-e063-6294a90ae231 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sportpharm LLC | 0749f61d-12e6-4280-8f41-bd4df81e7ae6 | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | ANDA074754 834022 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | b0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Amerisyn LLC | 5734e81e-2471-1314-e063-6294a90ac9fe | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hospira, Inc. | 8accbb78-fc64-45d5-69b0-35c23a1d2a2e | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Apotex Corp. | d9a186ba-74a9-b6d4-1109-1e045ba1763e | 2026-07-16 | Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | e46ebc7f-584e-e2b7-e053-2995a90ad17b | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | St. Mary's Medical Park Pharmacy | 2d552135-bde5-5fe9-e063-6394a90af433 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | f47d4365-40a8-445b-99cd-49edad6a8ffc | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | ANDA074754 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | dd489c86-08c0-4457-86f3-c4f36a70276c | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Injecta Medcial LLC | 515464a7-16c5-2811-e063-6294a90aa451 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Preferred Pharmaceuticals Inc. | 1e7ae5af-76b9-49a9-ba14-52b566929c22 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Redpharm Drug | 53cb9528-7640-1fd4-e063-6294a90a74ad | 2026-06-09 | Warnings, Adverse reactions | 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | 26a1761b-90bf-49c6-9e6a-f293af2296ce | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.