82139-0020 NDC - MIRABEGRON

Drug Information

Product NDC: 82139-0020
Proprietary Name:
Non Proprietary Name: Mirabegron
Active Ingredient(s): 1 kg/kg MIRABEGRON
Administration Route(s):
Dosage Form(s): POWDER

Labeler Information

Field Name	Field Value
Labeler Name:	RAKSHIT DRUGS PRIVATE LIMITED
Product Type:	BULK INGREDIENT
FDA Application Number:
Marketing Category:	BULK INGREDIENT
Start Marketing Date:	10/26/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	82139-0020-0	20 kg in 1 DRUM (82139-0020-0)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	82139-0020	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	BULK INGREDIENT	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Mirabegron	This is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAME	POWDER	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
START MARKETING DATE	10/26/2022	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
MARKETING CATEGORY NAME	BULK INGREDIENT	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	RAKSHIT DRUGS PRIVATE LIMITED	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	MIRABEGRON	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	1
ACTIVE INGRED UNIT	kg/kg

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This page was last updated on: 12/6/2025

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