NDC 80425-0139-01 - 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
- 80425-0139-01
- Package NDCs from labels
- 80425-0139-1, 80425-0139-3, 80425-0139-2, 80425-0139-01
- 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 | Proficient Rx LP | 014ba8d7-7ed3-4d4a-847a-22b65161117e | 2021-07-01 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Proficient Rx LP | fc8ba956-4d3d-4f52-ac8e-89d52a480b48 | 2021-06-01 | Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Sun Pharmaceutical Industries, Inc. | 2c76b8f9-5385-4c98-aebb-bdca8613d24b | 2018-10-24 | Warnings, Adverse reactions | 4EVE5946BQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.