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 | Mylan Pharmaceuticals Inc. | 2837a082-3a34-6f81-5e43-45a70295686b | 2024-08-31 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Aurobindo Pharma Limited | e93f6501-827d-474c-b660-765b7c0fb871 | 2024-08-26 | Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 415a5393-296f-30e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | ANDA074754 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 46dc8f62-e754-50e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | ANDA074754 834022 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Zydus Lifesciences Limited | 5a4192e8-d9e5-4f09-99f6-da5a648b1aac | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Zydus Pharmaceuticals (USA) Inc. | ffd84ef3-26ed-4810-952b-4f0e913c5e32 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | DR. REDDY'S LABORATORIES, INC. | 10827042-a2d4-44f9-837d-2023a3d552ff | 2024-08-01 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Sun Pharmaceutical Industries, Inc. | 29a92a7c-68d1-489b-ba27-d788b3153795 | 2024-07-29 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 2024-07-23 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Eugia US LLC | f520978f-9046-4ff8-b04d-0f615fdeae4d | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals,Inc. | ae2e626c-0019-7c4e-e053-2995a90a23be | 2024-07-17 | Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Alembic Pharmaceuticals Inc. | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| ACULAR LS | KETOROLAC TROMETHAMINE | Allergan, Inc. | 4fad0873-f79c-4f07-9fac-5060be6b38fe | 2024-06-21 | Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Pacific Pharma, Inc. | 8432a1c5-15e5-4e3d-8e2d-49646e6b7eda | 2024-06-21 | Warnings, Adverse reactions | 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | A-S Medication Solutions | 1580b751-15ff-4193-8f22-25a9a468989a | 2024-06-10 | Warnings, Adverse reactions | 4EVE5946BQ |
| ACUVAIL | KETOROLAC TROMETHAMINE | Allergan, Inc. | 3cea5803-a446-4d2c-9747-f3fb034332c8 | 2024-05-31 | Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Leading Pharma, LLC | c34b69c6-5cdf-41f6-8652-33bd8e9c6c70 | 2024-05-24 | Warnings, Adverse reactions | 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Hikma Pharmaceuticals USA Inc. | 0c2c75c9-ed7b-46a8-9543-429bf2d8f090 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals,Inc. | 155c9171-d394-9c28-e063-6394a90a8209 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Toronova II SUIK | KETOROLAC TROMETHAMINE | Asclemed USA, Inc. | b574ccc9-936c-4877-bd65-7f58f741b5e6 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | 4EVE5946BQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.