NDC 55154-8712

Myrbetriq

Mirabegron

Myrbetriq is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health. The primary component is Mirabegron.

• Product ID: 55154-8712_1b9ded22-d5c2-4380-8de6-1ff4a48da75f
• NDC: 55154-8712
• 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: Cardinal Health
• Substance Name: MIRABEGRON
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: beta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55154-8712-8

960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8712-8)

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

NDC SPL Data Element Entries

NDC 55154-8712-8 [55154871208]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE

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

Drug Details

Active Ingredients

Ingredient	Strength
MIRABEGRON	25 mg/1

OpenFDA Data

• SPL SET ID: aaaf3bea-1b21-4edf-9300-b7159ea9ede8
• Manufacturer:
  • Cardinal Health
• UNII:
  • MVR3JL3B2V
• RxNorm Concept Unique ID - RxCUI:
  • 1300803
  • 1300791
  • 1300797
  • 1300801
• UPC Code:
  • 0355154871281
  • 0355154871380

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