Prescription drug · NDA
Ilevro (Nepafenac) NDC 0078-0743
Nepafenac 3 mg/mL · Suspension/ drops · Ophthalmic · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Ilevro
- Generic name (nonproprietary)
- nepafenac
- Active ingredients
- Nepafenac — 3 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Ophthalmic
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- 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 0078-0743_4e6e6db9-e1cf-83cb-e063-6294a90a2420SPL ID 4e6e6db9-e1cf-83cb-e063-6294a90a2420SPL set ID f089b583-0310-4ca8-8d41-52b06b08d1edRxCUI 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.
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.
About NDC 0078-0743
- What is NDC 0078-0743?
- 0078-0743 is the product NDC for Ilevro (nepafenac), Nepafenac 3 mg/mL suspension/ drops, listed with the FDA by Novartis Pharmaceuticals Corporation.
- What drug is associated with this NDC?
- Ilevro (Nepafenac).
- What is the active ingredient?
- Nepafenac.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ilevro?
- 1 other product NDC are listed under this name. See all Ilevro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ilevro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ilevronepafenac | Nepafenac 3 mg/mL | Suspension/ dropsOphthalmic | Harrow Eye, LLC | 82667-400 | 82667-0400-03 |
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 | Harrow Eye, LLC | 82667-400 |