NDC 70518-2435

Myrbetriq

Mirabegron

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

Product ID70518-2435_97bf903f-9546-e409-e053-2a95a90acef6
NDC70518-2435
Product TypeHuman Prescription Drug
Proprietary NameMyrbetriq
Generic NameMirabegron
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-11-19
Marketing CategoryNDA / NDA
Application NumberNDA202611
Labeler NameREMEDYREPACK INC.
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 70518-2435-0

90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2435-0)
Marketing Start Date2019-11-19
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
MIRABEGRON50 mg/1

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
55154-8712Myrbetriqmirabegron
55154-8713Myrbetriqmirabegron
70518-2435Myrbetriqmirabegron

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