Prescription drug · ANDA
Ketorolac Tromethamine NDC 72189-555
Ketorolac tromethamine 10 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-555-10 | 72189055510 | 10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10)Marketed from Jun 3, 2024 | |
| 72189-555-15 | 72189055515 | 15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15)Marketed from Jun 3, 2024 | |
| 72189-555-20 | 72189055520 | 20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20)Marketed from Jun 3, 2024 | |
| 72189-555-30 | 72189055530 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30)Marketed from Jun 3, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216759
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-555_4c4aad0a-641f-1aa7-e063-6294a90a13daSPL ID 4c4aad0a-641f-1aa7-e063-6294a90a13daSPL set ID 19fffe42-a02d-26eb-e063-6294a90aea5aRxCUI 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
N472189055510followed by a unit qualifier and the quantityPackage 72189-0555-10. 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)
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 intravenous or intramuscular dosing of ketorolac tromethamine, and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessa…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216759
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 | St. Mary's Medical Park Pharmacy | 60760-704 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2171 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2444 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-248 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8701 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7265 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4161 |
| Ketorolac Tromethamine | Ketorolac tromethamine 10 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-275 |