Ketorolac Tromethamine NDC 60505-1003

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-1003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-1003Add 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
60505-1003-1	60505100301	1 BOTTLE, DROPPER in 1 CARTON (60505-1003-1) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 7, 2009
60505-1003-2	60505100302	1 BOTTLE, DROPPER in 1 CARTON (60505-1003-2) / 10 mL in 1 BOTTLE, DROPPERMarketed from Dec 7, 2009

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: Apotex Corp.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076109
Marketing start: Dec 7, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 60505-1003_7d61a595-be30-8226-a32b-c02325c581d9SPL ID 7d61a595-be30-8226-a32b-c02325c581d9SPL set ID d9a186ba-74a9-b6d4-1109-1e045ba1763eRxCUI 860107UNII 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

N460505100301 followed by a unit qualifier and the quantity

Package 60505-1003-01. 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 Jul 16, 2026.

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 temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 ) The treatment of inflammation following cataract surgery. ( 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	NuCare Pharmaceuticals, Inc.	68071-3880
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	63187-777