1. Home
  2. Labeler Index
  3. Astellas Pharma Us, Inc.
  4. 0469-0125
  5. NDC Package Code: 0469-0125-99 Xtandi

NDC Package 0469-0125-99 Xtandi

Enzalutamide Capsule Oral - 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:
0469-0125-99
Package Description:
1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE
Product Code:
0469-0125
Proprietary Name:
Xtandi
Non-Proprietary Name:
Enzalutamide
Substance Name:
Enzalutamide
Usage Information:
Enzalutamide is used to treat prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.
11-Digit NDC Billing Format:
00469012599
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1307303 - enzalutamide 40 MG Oral Capsule
  • RxCUI: 1307309 - Xtandi 40 MG Oral Capsule
  • RxCUI: 1307309 - enzalutamide 40 MG Oral Capsule [Xtandi]
  • RxCUI: 2390644 - enzalutamide 40 MG Oral Tablet
  • RxCUI: 2390646 - Xtandi 40 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astellas Pharma Us, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ENZALUTAMIDE 40 mg/1
    • Pharmacologic Class(es):
  • Androgen Receptor Antagonists - [MoA] (Mechanism of Action)
  • Androgen Receptor Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inducers - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203415
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-31-2012
    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 0469-0125-99?

    The NDC Packaged Code 0469-0125-99 is assigned to a package of 1 bottle in 1 carton / 120 capsule in 1 bottle of Xtandi, a human prescription drug labeled by Astellas Pharma Us, Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0469-0125 included in the NDC Directory?

    Yes, Xtandi with product code 0469-0125 is active and included in the NDC Directory. The product was first marketed by Astellas Pharma Us, Inc. on August 31, 2012 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 0469-0125-99?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0469-0125-99?

    The 11-digit format is 00469012599. 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
    4-4-20469-0125-995-4-200469-0125-99