Ketorolac Tromethamine NDC 68071-3880

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3880Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3880Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68071-3880-5	68071388005	1 BOTTLE, DROPPER in 1 CARTON (68071-3880-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jul 31, 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 — 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 076109
Marketing start: Dec 7, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 68071-3880_3b3cc686-c54a-af69-e063-6294a90aeef2SPL ID 3b3cc686-c54a-af69-e063-6294a90aeef2SPL set ID 3b3cc67c-e1ff-3a0a-e063-6394a90adb9aRxCUI 860107UNII 4EVE5946BQUPC 0368071388053
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

N468071388005 followed by a unit qualifier and the quantity

Package 68071-3880-05. 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 Jul 31, 2025.

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. The temporary relief of ocular itching due to seasonal allergic conjunctivitis ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076109

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076109
Product	Strength	Form · route	Labeler	Product NDC
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	63187-777
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Apotex Corp.	60505-1003