beta3-Adrenergic Agonist [EPC] - N0000185008

Name: Table of NDC products with beta3-adrenergic agonist
Creator: U.S. Food & Drug Administration
License: https://creativecommons.org/licenses/by-nc-sa/4.0/

Pharmacologic Class Information

Pharmacologic Code	N0000185008
Pharmacologic Name	beta3-Adrenergic Agonist
Pharmacologic Uses	beta-3 adrenergic agonist
Pharmacologic Concept	Established Pharmacologic Classes - [EPC]
Pharmacologic Concept Description	An established pharmacologic class is a term or phrase that is scientifically valid and clinically meaningful according to the following definitions: A scientifically valid pharmacologic class is supported by documented and submitted empiric evidence showing that the drug's pharmacologic class is known, not theoretical, and relevant and specific to the indication. A clinically meaningful pharmacologic class term or phrase enhances the ability of professionals to understand physiologic effects related to the indication or to anticipate undesirable effects that may be associated with the drug or pharmacologic class.

NDC Products with beta3-Adrenergic Agonist

The table contains 21 products whose active ingredient are classified under the same pharmacologic class beta3-Adrenergic Agonist [EPC].

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Status
67184-0572	Mirabgeorn	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Qilu Pharmaceutical Co., Ltd.	ACTIVE
70518-4631	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Extended Release	Oral	Remedyrepack Inc.	ACTIVE
0469-2602	Myrbetriq	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Astellas Pharma Us, Inc.	ACTIVE
68180-152	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Lupin Pharmaceuticals, Inc.	ACTIVE
71335-2810	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Bryant Ranch Prepack	ACTIVE
73336-075	Gemtesa	Non-Proprietary Name: Vibegron	Tablet, Film Coated	Oral	Sumitomo Pharma America, Inc.	ACTIVE
0469-5020	Myrbetriq	Non-Proprietary Name: Mirabegron	Granule, For Suspension, Extended Release	Oral	Astellas Pharma Us, Inc.	ACTIVE
70518-4304	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Extended Release	Oral	Remedyrepack Inc.	ACTIVE
71335-2808	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Bryant Ranch Prepack	ACTIVE
0469-2601	Myrbetriq	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Astellas Pharma Us, Inc.	ACTIVE
67184-0571	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Qilu Pharmaceutical Co., Ltd.	ACTIVE
68180-151	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Lupin Pharmaceuticals, Inc.	ACTIVE
69238-2861	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Amneal Pharmaceuticals Ny Llc	ACTIVE
70710-1159	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Extended Release	Oral	Zydus Pharmaceuticals (usa) Inc.	ACTIVE
70771-1752	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Extended Release	Oral	Zydus Lifesciences Limited	ACTIVE
70518-4665	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Remedyrepack Inc.	ACTIVE
71335-2807	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Bryant Ranch Prepack	ACTIVE
69238-2860	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Amneal Pharmaceuticals Ny Llc	ACTIVE
70771-1753	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Extended Release	Oral	Zydus Lifesciences Limited	ACTIVE
71335-2809	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Film Coated, Extended Release	Oral	Bryant Ranch Prepack	ACTIVE
70710-1160	Mirabegron	Non-Proprietary Name: Mirabegron	Tablet, Extended Release	Oral	Zydus Pharmaceuticals (usa) Inc.	ACTIVE