Mirabegron Tablet, Extended Release
NDC Package 70710-1160-1

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

Package Information

Mirabegron tablets is a medication used to treat overactive bladder. This formulation utilizes a tablet, extended release delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-1160 and is authorized under FDA application ANDA209488.

Identification & Billing

NDC Package Code
70710-1160-1
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
70710-1160
11-Digit Billing Format
70710116001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mirabegron
Non-Proprietary Name
Mirabegron
Substance Name
Mirabegron
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIRABEGRON 50 mg/1
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
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209488
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-23-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70710-1160). Click a package code to view its specific billing and regulatory data.

70710-1160-3
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
70710-1160-9
90 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 70710-1160-1 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Mirabegron, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This tablet, 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 Zydus Pharmaceuticals (usa) Inc. on January 23, 2024. 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 Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710116001. 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 (5-4-1)
70710-1160-1
11-Digit CMS (5-4-2)
70710-1160-01

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