Myrbetriq Granule, For Suspension, Extended Release
NDC Package 0469-5020-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Myrbetriq (mirabegron) granules is a medication used to treat overactive bladder. This formulation utilizes a granule, for suspension, extended release delivery system. Marketed by Astellas Pharma Us, Inc., this product is identified by NDC 0469-5020 and is authorized under FDA application NDA213801.

Identification & Billing

NDC Package Code
0469-5020-99
Package Description
1 BOTTLE in 1 CARTON / 100 mL in 1 BOTTLE
Product Code
0469-5020
11-Digit Billing Format
00469502099
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Myrbetriq
Non-Proprietary Name
Mirabegron
Substance Name
Mirabegron
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIRABEGRON 8 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Astellas Pharma Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213801
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-25-2021
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0469-5020-99 identifies a specific commercial package of 1 bottle in 1 carton / 100 ml in 1 bottle of Myrbetriq, a human prescription drug labeled by Astellas Pharma Us, Inc.. This granule, for suspension, extended release is formulated for oral use and contains mirabegron 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 Astellas Pharma Us, Inc. on March 25, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Astellas Pharma Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00469502099. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0469-5020-99
11-Digit CMS (5-4-2)
00469-5020-99

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