Efudex
NDC Package 0187-3203-10

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Efudex is a medication used on the skin to treat pre-cancerous and cancerous skin growths. Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-3203 and is authorized under FDA application NDA016831.

Identification & Billing

NDC Package Code
0187-3203-10
Package Description
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code
0187-3203
11-Digit Billing Format
00187320310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Efudex
Dosage Form
-
Usage Information
This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Fluorouracil belongs to a class of medications known as anti-metabolites. It works by blocking the growth of abnormal cells that cause the skin condition.

Regulatory & Marketing

Labeler Name
Bausch Health Us, Llc
FDA Application #
NDA016831
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-29-1970
End Marketing Date
01-31-2010
Listing Expiration
01-31-2010
Exclude Flag
D
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 (0187-3203). Click a package code to view its specific billing and regulatory data.

0187-3203-02
1 BOTTLE in 1 CARTON / 25 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 0187-3203-10 identifies a specific commercial package of 1 bottle in 1 carton / 10 ml in 1 bottle of Efudex, labeled by Bausch Health Us, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bausch Health Us, Llc on July 29, 1970. The current certification is valid through January 31, 2010.

What are the primary indications for this medication?

This medication is used on the skin to treat pre-cancerous and cancerous skin growths. Fluorouracil belongs to a class of medications known as anti-metabolites. It works by blocking the growth of abnormal cells that cause the skin condition.

How is this Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187320310. 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)
0187-3203-10
11-Digit CMS (5-4-2)
00187-3203-10

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