Prescription drug · NDA
Ilevro (nepafenac) NDC 82667-400
Nepafenac 3 mg/mL · Suspension/ drops · Ophthalmic · Harrow Eye, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82667-400-03 | 82667040003 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTICMarketed from May 1, 2024 |
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)
- Ilevro
- Generic name (nonproprietary)
- nepafenac
- Active ingredients
- Nepafenac — 3 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Harrow Eye, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203491
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 82667-400_4e6f184f-0de5-acca-e063-6394a90ac321SPL ID 4e6f184f-0de5-acca-e063-6394a90ac321SPL set ID 10f411d3-a81e-074a-e063-6294a90ab547RxCUI 1362132, 1365866UNII 0J9L7J6V8C
- Pharmacologic class
- 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
N482667040003followed by a unit qualifier and the quantityPackage 82667-0400-03. 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)
ILEVRO ® 0.3% is indicated for the treatment of pain and inflammation associated with cataract surgery. ILEVRO ® 0.3% is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203491
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 |
|---|---|---|---|---|
| Ilevronepafenac | Nepafenac 3 mg/mL | Suspension/ dropsOphthalmic | Novartis Pharmaceuticals Corporation | 0078-0743 |