Fluorouracil
NDC Package 10139-063-01

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.

Fluorouracil is used to treat various types of cancer. Marketed by Generamedix, this product is identified by NDC 10139-063 and is authorized under FDA application ANDA040743.

Identification & Billing

NDC Package Code
10139-063-01
Package Description
100 mL in 1 VIAL, SINGLE-DOSE
Product Code
10139-063
11-Digit Billing Format
10139006301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML

Clinical Specifications

Proprietary Name
Fluorouracil
Dosage Form
-
Usage Information
Fluorouracil is used to treat various types of cancer. It is a chemotherapy drug that is used to slow or stop cancer cell growth. You should be tested for a DPD enzyme deficiency before you start treatment with fluorouracil. Ask your doctor for more details.

Regulatory & Marketing

Labeler Name
Generamedix
FDA Application #
ANDA040743
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-30-2012
End Marketing Date
06-30-2014
Listing Expiration
06-30-2014
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 (10139-063). Click a package code to view its specific billing and regulatory data.

10139-063-11
10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (10139-063-10)
10139-063-12
10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (10139-063-20)
10139-063-50
50 mL in 1 VIAL, SINGLE-DOSE

* 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 10139-063-01 identifies a specific commercial package of 100 ml in 1 vial, single-dose of Fluorouracil, labeled by Generamedix. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. 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 Generamedix on August 30, 2012. The current certification is valid through June 30, 2014.

What are the primary indications for this medication?

Fluorouracil is used to treat various types of cancer. It is a chemotherapy drug that is used to slow or stop cancer cell growth. You should be tested for a DPD enzyme deficiency before you start treatment with fluorouracil. Ask your doctor for more details.

How is this Generamedix product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10139006301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 total billable units per package. 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 (5-3-2)
10139-063-01
11-Digit CMS (5-4-2)
10139-0063-01

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