Prescription drug · ANDA
Ketorolac Tromethamine NDC 80425-0489
Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0489-1 | 80425048901 | 9 TABLET, FILM COATED in 1 BOTTLE (80425-0489-1)Marketed from Jan 30, 2025 | |
| 80425-0489-2 | 80425048902 | 10 TABLET, FILM COATED in 1 BOTTLE (80425-0489-2)Marketed from Jan 30, 2025 | |
| 80425-0489-3 | 80425048903 | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0489-3)Marketed from Jan 30, 2025 | |
| 80425-0489-4 | 80425048904 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0489-4)Marketed from Jan 30, 2025 | |
| 80425-0489-5 | 80425048905 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0489-5)Marketed from Jan 30, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ketorolac Tromethamine
- Generic name (nonproprietary)
- ketorolac tromethamine
- Active ingredients
- Ketorolac tromethamine — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216651
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0489_2cf758ae-264f-cb5a-e063-6394a90aab02SPL ID 2cf758ae-264f-cb5a-e063-6394a90aab02SPL set ID 2cf7516b-ac86-ca72-e063-6394a90a4339RxCUI 834022UNII 4EVE5946BQ
- Pharmacologic class
- Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425048901followed by a unit qualifier and the quantityPackage 80425-0489-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets are indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and Ketorolac Tromethamine Tablets are to be used only as continuation treatment, if necess…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216651
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-7695 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Injecta Medcial LLC | 87234-7695 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7695 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-686 |