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Myrbetriq

mirabegron · Tablet, Film Coated, Extended Release

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Myrbetriq
Generic name
mirabegron
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Astellas Pharma US, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
6
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Mirabegron 25 mg/1 1300791 View
Mirabegron 50 mg/1 1300791 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic beta3-Agonists [MoA] MoA 3 members — no class page
Cytochrome P450 2D6 Inhibitors [MoA] MoA All 72 members
Cytochrome P450 3A Inhibitors [MoA] MoA All 89 members
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
beta3-Adrenergic Agonist [EPC] EPC 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
202611
Application type
NDA · New Drug Application
Approval date
June 28, 2012
Sponsor
APGDI
Products on application
2
Submissions recorded
12
Products approved under application 202611.
Product Trade name Form Strength Ingredient Status TE Flags
202611-001 MYRBETRIQ TABLET, EXTENDED RELEASE MIRABEGRON Prescription AB RLD RS
202611-002 MYRBETRIQ TABLET, EXTENDED RELEASE MIRABEGRON Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8772315 October 30, 2028 001 No U-2300 May 17, 2018
8772315 October 30, 2028 002 No U-2300 May 17, 2018
8772315*PED April 30, 2029 001 No —
8772315*PED April 30, 2029 002 No —
10842780 September 28, 2029 001 No U-3670 December 11, 2020
12097189 September 28, 2029 001 No U-2996 October 2, 2024
12097189 September 28, 2029 001 No U-3670 October 2, 2024
11707451 September 28, 2029 001 No U-2996 August 21, 2023
11707451 September 28, 2029 001 No U-3670 August 21, 2023
10842780 September 28, 2029 001 No U-2996 December 11, 2020
12059409 September 28, 2029 001 No August 28, 2024
10842780 September 28, 2029 002 No U-3670 December 11, 2020
12097189 September 28, 2029 002 No U-2996 October 2, 2024
12097189 September 28, 2029 002 No U-3670 October 2, 2024
11707451 September 28, 2029 002 No U-2996 August 21, 2023
11707451 September 28, 2029 002 No U-3670 August 21, 2023
10842780 September 28, 2029 002 No U-2996 December 11, 2020
12059409 September 28, 2029 002 No August 28, 2024
11707451*PED March 28, 2030 001 No —
12097189*PED March 28, 2030 001 No —
10842780*PED March 28, 2030 001 No —
12059409*PED March 28, 2030 001 No —
11707451*PED March 28, 2030 002 No —
12097189*PED March 28, 2030 002 No —
10842780*PED March 28, 2030 002 No —
12059409*PED March 28, 2030 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 202611.
Type No. Action Status Date Review
Supplement 17 Efficacy Approved March 25, 2021 Priority
Supplement 11 Efficacy Approved April 27, 2018 Standard
Supplement 12 Labeling Approved July 28, 2017 Standard
Supplement 7 Labeling Approved August 16, 2016 Standard
Supplement 8 Manufacturing (CMC) Approved August 1, 2016 Standard
Supplement 5 Labeling Approved November 2, 2015 Standard
Supplement 6 Labeling Approved August 10, 2015 Standard
Supplement 4 Manufacturing (CMC) Approved February 9, 2015 Standard
Supplement 3 Manufacturing (CMC) Approved March 13, 2014 Standard
Supplement 2 Manufacturing (CMC) Approved July 19, 2013 Standard
Supplement 1 Manufacturing (CMC) Approved March 4, 2013 Standard
Original application 1 Type 1 - New Molecular Entity Approved June 28, 2012 Standard

Review documents

  • 0 · Supplement · March 30, 2021
  • 0 · Supplement · March 26, 2021
  • 0 · Supplement · May 7, 2018
  • 0 · Supplement · May 3, 2018
  • 0 · Supplement · August 2, 2017
  • 0 · Supplement · July 31, 2017
  • 0 · Supplement · August 17, 2016
  • 0 · Supplement · August 16, 2016
  • 0 · Supplement · November 4, 2015
  • 0 · Supplement · November 4, 2015
  • 0 · Supplement · August 11, 2015
  • 0 · Supplement · August 11, 2015
  • 0 · Original application · August 10, 2012
  • 0 · Original application · June 28, 2012
  • 0 · Original application · June 28, 2012

Adverse event reports

Source: openFDA FAERS
38,466
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MIRABEGRON. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0469-2601-07 0469-2601 Astellas Pharma US, Inc. 4 CARTON in 1 TRAY (0469-2601-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK June 28, 2012
0469-2601-30 0469-2601 Astellas Pharma US, Inc. 1 BOTTLE in 1 CARTON (0469-2601-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE June 28, 2012
0469-2601-90 0469-2601 Astellas Pharma US, Inc. 1 BOTTLE in 1 CARTON (0469-2601-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE June 28, 2012
0469-2602-07 0469-2602 Astellas Pharma US, Inc. 4 CARTON in 1 TRAY (0469-2602-07) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK June 28, 2012
0469-2602-30 0469-2602 Astellas Pharma US, Inc. 1 BOTTLE in 1 CARTON (0469-2602-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE June 28, 2012
0469-2602-90 0469-2602 Astellas Pharma US, Inc. 1 BOTTLE in 1 CARTON (0469-2602-90) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE June 28, 2012
0469-2601 0469-2601 Astellas Pharma US, Inc. — June 28, 2012
0469-2602 0469-2602 Astellas Pharma US, Inc. — June 28, 2012

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.