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  5. NDC Package Code: 0781-6000-78 Difluprednate Ophthalmic

NDC Package 0781-6000-78 Difluprednate Ophthalmic

Emulsion Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0781-6000-78
Package Description:
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code:
0781-6000
Proprietary Name:
Difluprednate Ophthalmic
Non-Proprietary Name:
Difluprednate Ophthalmic
Substance Name:
Difluprednate
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.
11-Digit NDC Billing Format:
00781600078
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 804544 - difluprednate 0.05 % Ophthalmic Emulsion
  • RxCUI: 804544 - difluprednate 0.5 MG/ML Ophthalmic Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    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(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • DIFLUPREDNATE .5 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-6000-78?

    The NDC Packaged Code 0781-6000-78 is assigned to a package of 1 bottle in 1 carton / 5 ml in 1 bottle of Difluprednate Ophthalmic, a human prescription drug labeled by Sandoz Inc. The product's dosage form is emulsion and is administered via ophthalmic form.

    Is NDC 0781-6000 included in the NDC Directory?

    Yes, Difluprednate Ophthalmic with product code 0781-6000 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on May 15, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0781-6000-78?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0781-6000-78?

    The 11-digit format is 00781600078. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20781-6000-785-4-200781-6000-78