Prescription drug · NDA
Acular Ls (Ketorolac tromethamine) NDC 0023-9277
Ketorolac tromethamine 4 mg/mL · Solution/ drops · Ophthalmic · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-9277-05 | 00023927705 | 1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Aug 19, 2003 |
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)
- Acular Ls
- Generic name (nonproprietary)
- ketorolac tromethamine
- Active ingredients
- Ketorolac tromethamine — 4 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021528
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0023-9277_15504a86-2bf2-470a-ad3d-99132d07d42dSPL ID 15504a86-2bf2-470a-ad3d-99132d07d42dSPL set ID 4fad0873-f79c-4f07-9fac-5060be6b38feRxCUI 860103, 860105UNII 4EVE5946BQUPC 0300239277052
- 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
N400023927705followed by a unit qualifier and the quantityPackage 00023-9277-05. 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)
ACULAR LS ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ACULAR LS 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.
About NDC 0023-9277
- What is NDC 0023-9277?
- 0023-9277 is the product NDC for Acular Ls (ketorolac tromethamine), Ketorolac tromethamine 4 mg/mL solution/ drops, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acular Ls (Ketorolac Tromethamine).
- What is the active ingredient?
- Ketorolac tromethamine.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acular Ls?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Ketorolac Tromethamine | Ketorolac tromethamine 4 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-3550 |
| Ketorolac Tromethamine | Ketorolac tromethamine 4 mg/mL | Solution/ dropsOphthalmic | Pacific Pharma, Inc. | 60758-773 |