NDC 0469-5020

Myrbetriq

Mirabegron

Myrbetriq is a Oral Granule, For Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Astellas Pharma Us, Inc.. The primary component is Mirabegron.

• Product ID: 0469-5020_3614f7ea-e4c2-48dd-94fe-170bfaac4d68
• NDC: 0469-5020
• Product Type: Human Prescription Drug
• Proprietary Name: Myrbetriq
• Generic Name: Mirabegron
• Dosage Form: Granule, For Suspension, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2021-03-25
• Marketing Category: NDA /
• Application Number: NDA213801
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: MIRABEGRON
• Active Ingredient Strength: 8 mg/mL
• Pharm Classes: Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0469-5020-99

1 BOTTLE in 1 CARTON (0469-5020-99) > 100 mL in 1 BOTTLE

• Marketing Start Date: 2021-03-25
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "Myrbetriq" or generic name "Mirabegron"

NDC	Brand Name	Generic Name
0469-2601	Myrbetriq	mirabegron
0469-2602	Myrbetriq	mirabegron
0469-5020	Myrbetriq	mirabegron
55154-8712	Myrbetriq	mirabegron
55154-8713	Myrbetriq	mirabegron
70518-2435	Myrbetriq	mirabegron
70518-3158	Myrbetriq	mirabegron