Difluprednate Ophthalmic Emulsion
NDC Package 0781-6000-78

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

Package Information

Difluprednate Ophthalmic emulsions is a medication used to treat swelling and pain after eye surgery. This formulation utilizes a emulsion delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-6000 and is authorized under FDA application NDA022212.

Identification & Billing

NDC Package Code
0781-6000-78
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
0781-6000
11-Digit Billing Format
00781600078
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Difluprednate Ophthalmic
Non-Proprietary Name
Difluprednate Ophthalmic
Substance Name
Difluprednate
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
DIFLUPREDNATE .5 mg/mL
Usage Information
This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA022212
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-15-2013
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0781-6000-78 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Difluprednate Ophthalmic, a human prescription drug labeled by Sandoz Inc. This emulsion is formulated for ophthalmic use and contains difluprednate 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 Sandoz Inc on May 15, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781600078. 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)
0781-6000-78
11-Digit CMS (5-4-2)
00781-6000-78

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