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 ID0469-2602_3614f7ea-e4c2-48dd-94fe-170bfaac4d68
NDC0469-2602
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 NameAstellas Pharma US, Inc.
Substance NameMIRABEGRON
Active Ingredient Strength50 mg/1
Pharm ClassesAdrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

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 Date2012-06-28
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 0469-2602-71 [00469260271]

Myrbetriq TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA202611
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-06-28
Marketing End Date2020-12-31

NDC 0469-2602-30 [00469260230]

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

NDC 0469-2602-90 [00469260290]

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

Drug Details

Active Ingredients

IngredientStrength
MIRABEGRON50 mg/1

OpenFDA Data

SPL SET ID:ba9e9e15-e666-4c56-9271-2e24739cfa2d
Manufacturer
UNII
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"

    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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