mirabegron
mirabegron is listed in the FDA National Drug Code directory with 15 NDC codes, marketed under brand names including MIRABEGRON, Myrbetriq, Mirabgeorn. Available dosage forms: tablet, film coated, extended release, powder, granule, for suspension, extended release.
Drug Details
- Generic Name
- mirabegron
- Brand Names
- MIRABEGRON, Myrbetriq, Mirabgeorn, Mirabegron
- Application Number
- ANDA209485
- Sponsor
- Bryant Ranch Prepack
- NDC Codes
- 15
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE, POWDER, GRANULE, FOR SUSPENSION, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- MIRABEGRON
Indications and Usage
1 INDICATIONS AND USAGE Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. Pediatric use information is approved for Astellas Pharma Global Development, Inc.'s MYRBETRIQ (mirabegron extended-release tablets). However, due to Astellas Pharma Global Development, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.