Medicine
Mirabegron 50 mg extended-release tablet
Mirabegron 50 mg extended-release tablet is a generic prescription medicine for oral use, made by 6 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store and Dispense Store at 20°C to 25°C (68°F to 77°F), excursions permitted…
Key facts
- Active ingredient (INN)
- Mirabegron
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 90 tablets and 13 more
- Manufacturers
- Zydus LifesciencesIndiaLupinIndiaAmneal Pharmaceuticals NYAvKAREBryant Ranch PrepackRemedyrepack
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). 1
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BD12 Mirabegron
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 January 2024
- Identifiers
- RxCUI 1300801, 1300791DailyMed set ID 5f102149-ad27-4956-e063-6294a90ac6ad, d0054db9-e38a-4786-be2c-996fa5b8f47d, 00826723-d25e-498a-b8d4-d17e5c14dda5 +6NDC 73190-116, 70518-4665, 71335-2808 +6Application ANDA218543, ANDA209485, ANDA209488
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, extended release in 1 bottle | 70710-1160-1 | Zydus LifesciencesIndia | 23 January 2024 |
| 30 tablet, extended release in 1 bottle | 70710-1160-3 | Zydus LifesciencesIndia | 23 January 2024 |
| 90 tablet, extended release in 1 bottle | 70710-1160-9 | Zydus LifesciencesIndia | 23 January 2024 |
| 100 tablet, extended release in 1 bottle | 70771-1753-1 | Zydus LifesciencesIndia | 23 January 2024 |
| 30 tablet, extended release in 1 bottle | 70771-1753-3 | Zydus LifesciencesIndia | 23 January 2024 |
| 90 tablet, extended release in 1 bottle | 70771-1753-9 | Zydus LifesciencesIndia | 23 January 2024 |
| 30 tablet, film coated, extended release in 1 bottle | 68180-152-06 | LupinIndia | 3 September 2024 |
| 90 tablet, film coated, extended release in 1 bottle | 68180-152-09 | LupinIndia | 3 September 2024 |
| 30 tablet, film coated, extended release in 1 bottle | 69238-2861-1 | Amneal Pharmaceuticals NY | 19 April 2026 |
| 90 tablet, film coated, extended release in 1 bottle | 69238-2861-2 | Amneal Pharmaceuticals NY | 19 April 2026 |
| 1 bottle in 1 carton / 30 tablet, film coated, extended release in 1 bottle | 71335-2808-1 | Bryant Ranch Prepack | 26 September 2025 |
| 90 tablet, film coated, extended release in 1 bottle | 71335-2810-1 | Bryant Ranch Prepack | 26 September 2025 |
| 90 tablet, extended release in 1 bottle, plastic | 70518-4304-0 | Remedyrepack | 7 March 2025 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 70518-4665-0 | Remedyrepack | 22 May 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 73190-116-30 | AvKARE | 30 October 2026 |
| 90 tablet, film coated, extended release in 1 bottle | 73190-116-90 | AvKARE | 30 October 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Mirabegron 50 mg extended-release tablet.
Other strengths and forms of Mirabegron
Clinical summary
Mirabegron is a beta3-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. MedsAcross supplies Mirabegron for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MirabegronFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Myrbetriq prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Betmiga: European public assessment report (EPAR) · European Medicines Agency
Need Mirabegron 50 mg extended-release tablet for your hospital or patient?
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