NDC 0469-2602

Myrbetriq

Mirabegron

Myrbetriq is a Oral Tablet, Film Coated, 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: 0469-2602_3614f7ea-e4c2-48dd-94fe-170bfaac4d68
• NDC: 0469-2602
• Product Type: Human Prescription Drug
• Proprietary Name: Myrbetriq
• Generic Name: Mirabegron
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2012-06-28
• Marketing Category: NDA / NDA
• Application Number: NDA202611
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: MIRABEGRON
• Active Ingredient Strength: 50 mg/1
• 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 0469-2602-07

4 CARTON in 1 TRAY (0469-2602-07) > 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2012-06-28
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0469-2602-71 [00469260271]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202611
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-06-28
• Marketing End Date: 2020-12-31

NDC 0469-2602-30 [00469260230]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202611
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-06-28

NDC 0469-2602-90 [00469260290]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA202611
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-06-28

Drug Details

Active Ingredients

Ingredient	Strength
MIRABEGRON	50 mg/1

OpenFDA Data

• SPL SET ID: ba9e9e15-e666-4c56-9271-2e24739cfa2d
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • MVR3JL3B2V
• RxNorm Concept Unique ID - RxCUI:
  • 1300803
  • 1300791
  • 1300797
  • 1300801

Pharmacological Class

• beta3-Adrenergic Agonist [EPC]
• Adrenergic beta3-Agonists [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]

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