Quick answers
- What is Mirabegron used for?
- The FDA-approved label (Myrbetriq, Astellas Pharma US, Inc., August 1, 2024) says: “MYRBETRIQ is a 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, either alone or in combination with the muscarinic antagonist solifenacin succinate. • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mirabegron have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mirabegron?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mirabegron been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 5, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Mirabegron?
- 9 companies list prescription products of Mirabegron in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Astellas Pharma US, Inc..
What Mirabegron is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MYRBETRIQ is a 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, either alone or in combination with the muscarinic antagonist solifenacin succinate. • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. …
— FDA label: Myrbetriq, Astellas Pharma US, Inc., effective August 1, 2024. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release · Tablet, extended release · Granule, for suspension, extended release · For suspension, extended release |
|---|---|
| Route | Oral |
| Prescription products | 21 in the FDA NDC Directory |
| Brand names | Myrbetriq, Mirabgeorn |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| mirabegron 25 mg tablet, extended release | Generic | $9.02 per tablet |
| mirabegron 25 mg tablet, film coated, extended release | Generic | $9.02 per tablet |
| mirabegron 25 mg tablet, film coated, extended release | Brand: Myrbetriq | $14.67 per tablet |
| mirabegron 50 mg tablet, extended release | Generic | $9.15 per tablet |
| mirabegron 50 mg tablet, film coated, extended release | Generic | $9.15 per tablet |
| mirabegron 50 mg tablet, film coated, extended release | Brand: Myrbetriq | $14.70 per tablet |
| mirabegron 8 mg/mL for suspension, extended release | Generic | $1.74 per mL |
| mirabegron 8 mg/mL granule, for suspension, extended release | Brand: Myrbetriq | $2.21 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack4 products
- Remedyrepack Inc.3 products
- Astellas Pharma US, Inc.3 products
- Amneal Pharmaceuticals NY LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Zydus Lifesciences Limited2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Ascend Laboratories, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202611 MYRBETRIQ | Apgdi | June 28, 2012 | 11, latest March 25, 2021 2021: Efficacy · 2018: Efficacy · 2017: Labeling |
| NDA213801 MYRBETRIQ GRANULES | Apgdi | March 25, 2021 | — |
Generic approvals (5)
- ANDA209485Lupin · September 28, 2022
- ANDA209488Zydus Pharms · September 29, 2022
- ANDA217989Qilu · June 30, 2025
- ANDA218543Msn · November 4, 2025
- ANDA219323Alkem Labs Ltd · January 20, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 5, 2026 · Class II · Ongoing · D-0745-2026
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710- — Zydus Pharmaceuticals (USA) Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Myrbetriq, Astellas Pharma US, Inc., effective August 1, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →