Data / Drug companies / Mirabegron
Mirabegron: 10 companies and 23 products in the FDA NDC directory
Mirabegron is listed in the FDA National Drug Code Directory by 10 companies, with 23 products in commercial distribution. 20 of the products (87.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, extended release; tablet, extended release; granule, for suspension, extended release, and the newest product started marketing on October 30, 2026.
SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.
- Companies listing it
- 10
- Products
- 23
- Generic (ANDA) products
- 20 (87.0%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Myrbetriq, Mirabgeorn
- openFDA record search
- api.fda.gov
Companies that list mirabegron
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 4 | tablet, film coated, extended release | Generic drugs (ANDA) | September 3, 2024 |
| Astellas Pharma US, Inc. | 3 | tablet, film coated, extended release; granule, for suspension, extended release | New drug applications (NDA) | March 25, 2021 |
| Remedyrepack Inc. | 3 | tablet, extended release; tablet, film coated, extended release | Generic drugs (ANDA) | May 22, 2026 |
| Amneal Pharmaceuticals NY LLC | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | April 19, 2026 |
| AvKARE | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | October 30, 2026 |
| Lupin Pharmaceuticals, Inc. | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | September 3, 2024 |
| Qilu Pharmaceutical Co., Ltd. | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | June 30, 2025 |
| Zydus Lifesciences Limited | 2 | tablet, extended release | Generic drugs (ANDA) | January 23, 2024 |
| Zydus Pharmaceuticals USA Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | January 23, 2024 |
| Ascend Laboratories, LLC | 1 | for suspension, extended release | Generic drugs (ANDA) | June 15, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated, extended release | 15 | 65.2% |
| Tablet, extended release | 6 | 26.1% |
| Granule, for suspension, extended release | 1 | 4.3% |
| For suspension, extended release | 1 | 4.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 20 | 87% |
| New drug applications (NDA) | 3 | 13% |
Pharmacologic classes
| Class | Products |
|---|---|
| beta3-Adrenergic Agonist | 23 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.