Medicine
Mirabegron 8 mg/mL powder for extended-release oral suspension
Mirabegron 8 mg/mL powder for extended-release oral suspension is a generic prescription medicine for oral use, 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 mirabegron for extended-release oral suspension at…
Key facts
- Active ingredient (INN)
- Mirabegron
- Brand
- Sold under the generic name
- Strength
- 8 mg/mL
- Dosage form
- Powder for extended-release oral suspension
- Route
- Oral
- Packs
- 1 pouch
- Manufacturer
- Ascend LaboratoriesIndia
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store mirabegron for extended-release oral suspension at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). Store the reconstituted suspension at 20°C to 25°C (68°F to 77°F) for up to 28 days.
- 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
- 15 June 2026
- Identifiers
- RxCUI 2541233DailyMed set ID 1c9022af-4841-4f3f-9737-1c5eef58e86bNDC 67877-890Application ANDA219323
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 pouch in 1 carton / 1 bottle in 1 pouch / 100 mL in 1 bottle | 67877-890-88 | Ascend LaboratoriesIndia | 15 June 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
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 8 mg/mL powder for extended-release oral suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.