Prescription drug · NDA AUTHORIZED GENERIC
Ketorolac Tromethamine NDC 60758-773
Ketorolac tromethamine 4 mg/mL · Solution/ drops · Ophthalmic · Pacific Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60758-773-05 | 60758077305 | 1 BOTTLE, DROPPER in 1 CARTON (60758-773-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 21, 2013 |
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 — 4 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Pacific Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021528
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 60758-773_92d01843-b71d-45d6-b752-2c935c6740a2SPL ID 92d01843-b71d-45d6-b752-2c935c6740a2SPL set ID 8432a1c5-15e5-4e3d-8e2d-49646e6b7edaRxCUI 860103UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460758077305followed by a unit qualifier and the quantityPackage 60758-0773-05. 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 reduction of ocular pain and burning/stinging following corneal refractive surgery. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021528
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 |
|---|---|---|---|---|
| Acular Lsketorolac tromethamine | Ketorolac tromethamine 4 mg/mL | Solution/ dropsOphthalmic | Allergan, Inc. | 0023-9277 |
| Ketorolac Tromethamine | Ketorolac tromethamine 4 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-3550 |