NDC 70518-3158

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 ID70518-3158_c72d36fe-33e6-2944-e053-2a95a90a9275
NDC70518-3158
Product TypeHuman Prescription Drug
Proprietary NameMyrbetriq
Generic NameMirabegron
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-07-15
Marketing CategoryNDA /
Application NumberNDA202611
Labeler NameREMEDYREPACK INC.
Substance NameMIRABEGRON
Active Ingredient Strength25 mg/1
Pharm Classesbeta3-Adrenergic Agonist [EPC],Adrenergic beta3-Agonists [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70518-3158-0

30 POUCH in 1 BOX (70518-3158-0) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-3158-1)
Marketing Start Date2021-07-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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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