1. Home
  2. Labeler Index
  3. Gland Pharma Limited
  4. 68083-269
  5. NDC Package Code: 68083-269-10 Fluorouracil

NDC Package 68083-269-10 Fluorouracil

Injection, Solution Intravenous - 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:
68083-269-10
Package Description:
10 VIAL in 1 CARTON / 10 mL in 1 VIAL (68083-269-01)
Product Code:
68083-269
Proprietary Name:
Fluorouracil
Non-Proprietary Name:
Fluorouracil
Substance Name:
Fluorouracil
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.
11-Digit NDC Billing Format:
68083026910
NDC to RxNorm Crosswalk:
  • RxCUI: 1791701 - fluorouracil 500 MG in 10 ML Injection
  • RxCUI: 1791701 - 10 ML fluorouracil 50 MG/ML Injection
  • RxCUI: 1791701 - 10 ML 5-5-fluorouracil 50 MG/ML Injection
  • RxCUI: 1791701 - 10 ML 5-FU 50 MG/ML Injection
  • RxCUI: 1791701 - fluorouracil 500 MG per 10 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • FLUOROURACIL 50 mg/mL
    • Pharmacologic Class(es):
  • Nucleic Acid Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Metabolic Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210123
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-07-2017
    Listing Expiration Date:
    12-31-2025
    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 68083-269-10?

    The NDC Packaged Code 68083-269-10 is assigned to a package of 10 vial in 1 carton / 10 ml in 1 vial (68083-269-01) of Fluorouracil, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 68083-269 included in the NDC Directory?

    Yes, Fluorouracil with product code 68083-269 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on November 07, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68083-269-10?

    The 11-digit format is 68083026910. 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 5-3-2 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
    5-3-268083-269-105-4-268083-0269-10