Mirabegron For Suspension, Extended Release
NDC Package 67877-890-88

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

Package Information

Mirabegron for suspensions is a medication used to treat overactive bladder. This formulation utilizes a for suspension, extended release delivery system. Marketed by Ascend Laboratories, Llc, this product is identified by NDC 67877-890 and is authorized under FDA application ANDA219323.

Identification & Billing

NDC Package Code
67877-890-88
Package Description
1 POUCH in 1 CARTON / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE
Product Code
67877-890
11-Digit Billing Format
67877089088
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mirabegron
Non-Proprietary Name
Mirabegron
Substance Name
Mirabegron
Dosage Form
For Suspension, Extended Release - A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period.
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
Ascend Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219323
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2026
Listing Expiration
12-31-2027
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 67877-890-88 identifies a specific commercial package of 1 pouch in 1 carton / 1 bottle in 1 pouch / 100 ml in 1 bottle of Mirabegron, a human prescription drug labeled by Ascend Laboratories, Llc. This 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 Ascend Laboratories, Llc on June 15, 2026. The current certification is valid through December 31, 2027.

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 Ascend Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67877089088. 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 (5-3-2)
67877-890-88
11-Digit CMS (5-4-2)
67877-0890-88

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