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  5. NDC Package Code: 65372-1202-2 Mirabegron

NDC Package 65372-1202-2 Mirabegron

Powder - View Billable Units, 11-Digit Format, RxNorm

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.

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:
65372-1202-2
Package Description:
20 kg in 1 DRUM
Product Code:
65372-1202
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:
65372120202
Product Type:
Bulk Ingredient
Labeler Name:
Jubilant Pharmova Limited
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
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    07-26-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 65372-1202-2?

    The NDC Packaged Code 65372-1202-2 is assigned to an UNFINISHED drug package of 20 kg in 1 drum of Mirabegron, a bulk ingredient labeled by Jubilant Pharmova Limited. The product's dosage form is powder and is administered via form.

    Is NDC 65372-1202 included in the NDC Directory?

    Yes, Mirabegron is an UNFINISHED PRODUCT with code 65372-1202 that is active and included in the NDC Directory. The product was first marketed by Jubilant Pharmova Limited on July 26, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65372-1202-2?

    The 11-digit format is 65372120202. 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
    5-4-165372-1202-25-4-265372-1202-02