Fluorouracil Injection, Solution
NDC Package 63323-117-28

11-digit billing NDC: 63323011728 · Billing unit: ML · 200 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fluorouracil injection is fluorouracil is used to treat various types of cancer. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-117 and is authorized under FDA application ANDA040279.

Identification & Billing

NDC Package Code
63323-117-28
Package Description
10 VIAL, SINGLE-DOSE in 1 TRAY / 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-41)
Product Code
63323-117
11-Digit Billing Format
63323011728
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
200 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluorouracil
Non-Proprietary Name
Fluorouracil
Substance Name
Fluorouracil
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
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
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040279
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2017
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 (63323-117). Click a package code to view its specific billing and regulatory data.

63323-117-10
10 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-00)
63323-117-18
10 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-43)
63323-117-19
10 VIAL, SINGLE-DOSE in 1 TRAY / 10 mL in 1 VIAL, SINGLE-DOSE (63323-117-31)
63323-117-20
10 VIAL, SINGLE-DOSE in 1 TRAY / 20 mL in 1 VIAL, SINGLE-DOSE (63323-117-01)
63323-117-51
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
63323-117-58
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
63323-117-59
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
63323-117-61
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
63323-117-68
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
63323-117-69
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

* 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 63323-117-28 identifies a specific commercial package of 10 vial, single-dose in 1 tray / 20 ml in 1 vial, single-dose (63323-117-41) of Fluorouracil, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 200 billable units per package. This injection, solution is formulated for intravenous use and contains fluorouracil 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 Fresenius Kabi Usa, Llc on January 02, 2017. The current certification is valid through December 31, 2027.

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 Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323011728. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 200 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)
63323-117-28
11-Digit CMS (5-4-2)
63323-0117-28

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