Acuvail (ketorolac tromethamine) NDC 0023-3507

NDC codes

FDA NDC Directory

Product NDC (as listed)0023-3507Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00023-3507Add 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
0023-3507-05	00023350705	5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2009 · Sample package
0023-3507-31	00023350731	3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Acuvail
Generic name (nonproprietary): ketorolac tromethamine
Active ingredients: Ketorolac tromethamine — 4.5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Allergan, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022427
Marketing start: Aug 1, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 0023-3507_ee96bc53-04b7-4ea7-8fab-835ed3648561SPL ID ee96bc53-04b7-4ea7-8fab-835ed3648561SPL set ID 3cea5803-a446-4d2c-9747-f3fb034332c8RxCUI 858364, 858366UNII 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

N400023350705 followed by a unit qualifier and the quantity

Package 00023-3507-05. 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 May 31, 2024.

Indications (excerpt from the label)

ACUVAIL ® is indicated for the treatment of pain and inflammation following cataract surgery. ACUVAIL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)