NDC 55154-8713

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 ID55154-8713_1b9ded22-d5c2-4380-8de6-1ff4a48da75f
NDC55154-8713
Product TypeHuman Prescription Drug
Proprietary NameMyrbetriq
Generic NameMirabegron
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-06-28
Marketing CategoryNDA / NDA
Application NumberNDA202611
Labeler NameCardinal Health
Substance NameMIRABEGRON
Active Ingredient Strength50 mg/1
Pharm Classesbeta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55154-8713-8

1080 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-8713-8)
Marketing Start Date2012-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-8713-8 [55154871308]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202611
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-28

Drug Details

Active Ingredients

IngredientStrength
MIRABEGRON50 mg/1

OpenFDA Data

SPL SET ID:aaaf3bea-1b21-4edf-9300-b7159ea9ede8
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0469-2601Myrbetriqmirabegron
    0469-2602Myrbetriqmirabegron
    0469-5020Myrbetriqmirabegron
    55154-8712Myrbetriqmirabegron
    55154-8713Myrbetriqmirabegron
    70518-2435Myrbetriqmirabegron
    70518-3158Myrbetriqmirabegron

    Trademark Results [Myrbetriq]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYRBETRIQ
    MYRBETRIQ
    85595770 4263728 Live/Registered
    Astellas Pharma Inc.
    2012-04-12

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