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Active ingredient

Mirabegron

21 finished FDA listings contain Mirabegron as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MIRABEGRON
Dosage forms
For Suspension, Extended Release, Granule, For Suspension, Extended Release, Tablet, Extended Release, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
9
Strengths listed
25 mg/1 · 50 mg/1 · 8 mg/ml
Brand names in FDA listings
Mirabgeorn, Myrbetriq

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1300786

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 202611APGDI2012-06-282
NDA 213801APGDI2021-03-251
ANDA 209485LUPIN2022-09-287
ANDA 209488ZYDUS PHARMS2022-09-296
ANDA 217989QILU2025-06-302
ANDA 218543MSN2025-11-042
ANDA 219323ALKEM LABS LTD2026-01-201

Official labeling on DailyMed

Showing the 12 most recent of 14 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.