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  5. NDC Package Code: 70518-2435-0 Myrbetriq

NDC Package 70518-2435-0 Myrbetriq

Mirabegron Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70518-2435-0
Package Description:
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code:
70518-2435
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:
70518243500
NDC to RxNorm Crosswalk:
  • RxCUI: 1300801 - mirabegron 50 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1300801 - 24 HR mirabegron 50 MG Extended Release Oral Tablet
  • RxCUI: 1300801 - mirabegron 50 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1300803 - Myrbetriq 50 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1300803 - 24 HR mirabegron 50 MG Extended Release Oral Tablet [Myrbetriq]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MIRABEGRON 50 mg/1
    • 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:
    NDA202611
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-19-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70518-2435-130 POUCH in 1 BOX / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2435-2)
    70518-2435-330 POUCH in 1 BOX / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2435-4)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70518-2435-0?

    The NDC Packaged Code 70518-2435-0 is assigned to a package of 90 tablet, film coated, extended release in 1 bottle, plastic of Myrbetriq, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 70518-2435 included in the NDC Directory?

    Yes, Myrbetriq with product code 70518-2435 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on November 19, 2019 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 70518-2435-0?

    The 11-digit format is 70518243500. 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 5-4-1 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
    5-4-170518-2435-05-4-270518-2435-00