NDC 80425-0267-01 - 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
- 80425-0267
- Requested NDC
- 80425-0267-01
- Package NDCs from labels
- 80425-0267-1, 80425-0267-2, 80425-0267-3, 80425-0267-4, 80425-0267-5, 80425-0267-01
- 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 |
|---|---|---|---|---|---|---|
| 80425-0267-1 | Ketorolac Tromethamine | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | 3 | |
| 80425-0267-2 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 3 | |
| 80425-0267-3 | Ketorolac Tromethamine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 80425-0267-4 | Ketorolac Tromethamine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 3 | |
| 80425-0267-5 | Ketorolac Tromethamine | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0267 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, 5 package rows | 20250102_f4e7f1c8-e458-0860-e053-2a95a90a1bf0.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0267-1 | EA - Each | 80425-0267 | 7f333244-4aa6-487e-9bfa-3c425d655b2f | 1 | 2023-04-07 |
| 80425-0267-2 | EA - Each | 80425-0267 | 44667709-05c6-4da2-bdda-fffbed00dfa1 | 1 | 2023-04-07 |
| 80425-0267-3 | EA - Each | 80425-0267 | 0b79c085-7336-4a3b-aecf-f92f2256cbd0 | 1 | 2023-04-07 |
| 80425-0267-4 | EA - Each | 80425-0267 | 89140c3e-8295-4419-960c-9f33244ecd3f | 1 | 2023-04-07 |
| 80425-0267-5 | EA - Each | 80425-0267 | 58a927a8-9ee5-408c-aa6c-a943444b53e5 | 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 | NuCare Pharmaceuticals, Inc. | 415a5393-296f-30e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | NuCare Pharmaceuticals, Inc. | 46dc8f62-e754-50e3-e054-00144ff8d46c | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 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 | ANDA215788 43598-139 834022 3afdebc5-20aa-48f5-9a14-bf672ab422cd 10827042-a2d4-44f9-837d-2023a3d552ff 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 |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | Leading Pharma, LLC | 04df9620-6dcb-494a-83e2-6d28036be974 | 2024-02-16 | Boxed warning, Warnings, Adverse reactions | 834022 4EVE5946BQ |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | A-S Medication Solutions | a1ebb51e-4658-4852-bf90-1983a3d44783 | 2023-12-10 | Warnings, Adverse reactions | 4EVE5946BQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.