Ketorolac Tromethamine NDC 72189-335

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-335Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0335Add 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
72189-335-05	72189033505	5 mL in 1 BOTTLE (72189-335-05)Marketed from Mar 7, 2022

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 — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Direct Rx
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203410
Marketing start: Mar 7, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 72189-335_2c3d8ffc-3ef5-cfa1-e063-6394a90a868eSPL ID 2c3d8ffc-3ef5-cfa1-e063-6394a90a868eSPL set ID d9a589b4-bd32-0e45-e053-2a95a90ae67dRxCUI 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

N472189033505 followed by a unit qualifier and the quantity

Package 72189-0335-05. 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 Jan 21, 2025.

Indications (excerpt from the label)

Before you use Ketorolac Tromethamine Ophthalmic solution 0.5% for the first time: 1.Check to make sure that the tamper evident ring between the bottle and the cap is not broken ( See Figure A). If the tamper evident ring is broken or missing, contact your pharmacist. [Img-fig-a] 2.Tear off the tamper evident ring ( See Figure B). [Img-fig-b] 3.To open the bottle, remove the cap by turning it in the counterclockwise direction ( See Figure C). [Img-fig-c] This Instructions for Use has been approved by the U.S. Food and Drug Administration. Rev.10/2021

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203410

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

FDA NDC Directory listings under ANDA 203410
Product	Strength	Form · route	Labeler	Product NDC
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	SolutionOphthalmic	Preferred Pharmaceuticals Inc.	68788-8549
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	SolutionOphthalmic	Micro Labs Limited	42571-137
Ketorolac Tromethamine	Ketorolac tromethamine 5 mg/mL	SolutionOphthalmic	Bryant Ranch Prepack	72162-2384