Prescription drug · ANDA
Ketorolac Tromethamine NDC 68071-3684
Ketorolac tromethamine 5 mg/mL · Solution/ drops · Ophthalmic · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3684-5 | 68071368405 | 1 BOTTLE, DROPPER in 1 CARTON (68071-3684-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 18, 2024 |
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 — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218204
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3684_2266e65b-4f99-374c-e063-6394a90ab332SPL ID 2266e65b-4f99-374c-e063-6394a90ab332SPL set ID 2266e650-a0e9-027d-e063-6394a90a795dRxCUI 860107UNII 4EVE5946BQUPC 0368071368451
- 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468071368405followed by a unit qualifier and the quantityPackage 68071-3684-05. 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 .
Indications (excerpt from the label)
Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti- inflammatory indicated for: The treatment of inflammation following cataract surgery. ( 1 ) The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218204
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 5 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-138 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-139 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-140 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | Solution/ dropsOphthalmic | Leading Pharma, LLC | 69315-322 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | Redpharm Drug | 67296-2210 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2253 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | SolutionOphthalmic | SOLA Pharmaceuticals, LLC | 70512-790 |
| Ketorolac Tromethamine | Ketorolac tromethamine 5 mg/mL | Solution/ dropsOphthalmic | Redpharm Drug | 67296-2318 |