Ilevro Suspension/ Drops
NDC Package 0078-0743-03

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ilevro (nepafenac) suspension/ dropses is a medication used to relieve eye pain, irritation, and redness following cataract eye surgery. This formulation utilizes a suspension/ drops delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0743 and is authorized under FDA application NDA203491.

Identification & Billing

NDC Package Code
0078-0743-03
Package Description
1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE
Product Code
0078-0743
11-Digit Billing Format
00078074303
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ilevro
Non-Proprietary Name
Nepafenac
Substance Name
Nepafenac
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
NEPAFENAC 3 mg/mL
Pharmacologic Class
Usage Information
This medication is used to relieve eye pain, irritation, and redness following cataract eye surgery. Nepafenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances (prostaglandins) in your body that cause pain and swelling.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA203491
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-20-2012
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0078-0743). Click a package code to view its specific billing and regulatory data.

0078-0743-96
1 BOTTLE in 1 CARTON / .8 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0743-03 identifies a specific commercial package of 1 bottle in 1 carton / 3 ml in 1 bottle of Ilevro, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This suspension/ drops is formulated for ophthalmic use and contains nepafenac as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on December 20, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to relieve eye pain, irritation, and redness following cataract eye surgery. Nepafenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances (prostaglandins) in your body that cause pain and swelling.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078074303. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-0743-03
11-Digit CMS (5-4-2)
00078-0743-03

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.