FDA label
What is mirabegron used for?
The FDA-approved uses of mirabegron, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for mirabegron (tablet, film coated, extended release) lists 2 uses: Adult Overactive Bladder (OAB); Pediatric Neurogenic Detrusor Overactivity (NDO).
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Mirabegron, tablet, film coated, extended release
Indications and Usage, quoted from the label by Amneal Pharmaceuticals NY LLC (ANDA218543). Cross-references to other label sections are left out.
Adult Overactive Bladder (OAB)
Mirabegron Monotherapy
Mirabegron is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Pediatric Neurogenic Detrusor Overactivity (NDO)
Mirabegron
Mirabegron is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.
Source: DailyMed label, set id e597023d-6dcc-4d9e-8ce0-2d28a5d862f3, version 4, effective March 26, 2026. NDC 69238-2860, one of 11 listings for this product.
Mirabegron, tablet, extended release
Indications and Usage, quoted from the label by Zydus Pharmaceuticals (USA) Inc. (ANDA209488). Cross-references to other label sections are left out.
Adult Overactive Bladder (OAB)
Mirabegron 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 Neurogenic Detrusor Overactivity (NDO)
Mirabegron extended-release tablets are indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.
Source: DailyMed label, set id 2e40eb74-3b2a-47f7-bf31-fe27484f9bd2, version 3, effective October 9, 2024. NDC 70710-1159, one of 6 listings for this product.
Mirabegron, for suspension, extended release
Indications and Usage, quoted from the label by Ascend Laboratories, LLC (ANDA219323). Cross-references to other label sections are left out.
Pediatric Neurogenic Detrusor Overactivity (NDO)
Mirabegron for Extended-Release Oral Suspension
Mirabegron for extended-release oral suspension is indicated for the treatment of NDO in pediatric patients aged 3 years and older.
Source: DailyMed label, set id 1c9022af-4841-4f3f-9737-1c5eef58e86b, version 7, effective May 22, 2026. NDC 67877-890, one of 1 listing for this product.
Questions
What is mirabegron used for?
The FDA label for mirabegron (tablet, film coated, extended release) lists 2 uses: Adult Overactive Bladder (OAB); Pediatric Neurogenic Detrusor Overactivity (NDO).
What drug class is mirabegron?
FDA lists mirabegron in the beta3-Adrenergic Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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