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  5. NDC Package Code: 0469-5020-99 Myrbetriq

NDC Package 0469-5020-99 Myrbetriq

Mirabegron Granule, For Suspension, Extended Release 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:
0469-5020-99
Package Description:
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code:
0469-5020
Proprietary Name:
Myrbetriq
Non-Proprietary Name:
Mirabegron
Substance Name:
Mirabegron
Usage Information:
This medication is used to treat overactive bladder. Overactive bladder is a problem with how your bladder stores urine that causes a sudden urge to urinate. The urge may be hard to control, and overactive bladder symptoms may include frequent urination, strong sudden urges to urinate, or involuntary loss of urine (incontinence). Mirabegron works by relaxing a certain bladder muscle (detrusor), which helps the bladder hold more urine and lessens symptoms of overactive bladder.
11-Digit NDC Billing Format:
00469502099
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1300791 - mirabegron 25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1300791 - 24 HR mirabegron 25 MG Extended Release Oral Tablet
  • RxCUI: 1300791 - mirabegron 25 MG 24 HR Release Tablet
  • RxCUI: 1300797 - Myrbetriq 25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1300797 - 24 HR mirabegron 25 MG Extended Release Oral Tablet [Myrbetriq]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astellas Pharma Us, Inc.
    Dosage Form:
    Granule, For Suspension, Extended Release - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the extended release system achieves slow release of the drug over an extended period of time and maintains constant drug levels in the blood or target tissue.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MIRABEGRON 8 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic beta3-Agonists - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
  • beta3-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA213801
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-25-2021
    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 0469-5020-99?

    The NDC Packaged Code 0469-5020-99 is assigned to a package of 1 bottle in 1 carton / 100 ml in 1 bottle of Myrbetriq, a human prescription drug labeled by Astellas Pharma Us, Inc.. The product's dosage form is granule, for suspension, extended release and is administered via oral form.

    Is NDC 0469-5020 included in the NDC Directory?

    Yes, Myrbetriq with product code 0469-5020 is active and included in the NDC Directory. The product was first marketed by Astellas Pharma Us, Inc. on March 25, 2021 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 0469-5020-99?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0469-5020-99?

    The 11-digit format is 00469502099. 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
    4-4-20469-5020-995-4-200469-5020-99