Mirabegron Powder
NDC Package 65372-1202-2

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Mirabegron powders is a medication used to treat overactive bladder. This formulation utilizes a powder delivery system. Marketed by Jubilant Biosys Limited, this product is identified by NDC 65372-1202.

Identification & Billing

NDC Package Code
65372-1202-2
Package Description
20 kg in 1 DRUM
Product Code
65372-1202
11-Digit Billing Format
65372120202

Clinical Specifications

Proprietary Name
Mirabegron
Non-Proprietary Name
Mirabegron
Substance Name
Mirabegron
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
MIRABEGRON 1 kg/kg
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
Jubilant Biosys Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-26-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65372-1202-2 identifies a specific commercial package of 20 kg in 1 drum of Mirabegron (UNFINISHED drug), a bulk ingredient labeled by Jubilant Biosys Limited. This powder is formulated for 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 Jubilant Biosys Limited on July 26, 2019. 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 Jubilant Biosys Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65372120202. 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)
65372-1202-2
11-Digit CMS (5-4-2)
65372-1202-02

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