DrugDashboards

Mirabegron

Mirabegron · MIRABEGRON 25 mg/1 · Tablet, Extended Release · Oral · Zydus Pharmaceuticals (USA) Inc.

NDC 70710-1159-09 · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price has held steady around $9.40 per unit over the past year. A Class II recall hit this product in the past year (Zydus Pharmaceuticals (USA) Inc). Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$9.40per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$10.17per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$19.10per TABweighted avg manufacturer price $10.9170 · Aug 1, 2026203% of what pharmacies pay — higher than 86% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 70710-1159-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$6.73per unit
middle half $5.95$8.93 · 1,099 plans · Apr 1, 2026
Est. net of rebates
≈ $6.73
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
20%of plans cover it
tier 3 · prior auth 0% · step therapy 2% · qty limit 75%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 8 quarters since 2024.

NADAC price per unit

$0$5.00$10.00$15.00Jul 2024Sep 2026$9.40
27 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$281.98
#90 count
$845.93

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$1.0M
3,467 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

25Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 3 active manufacturers+10
  • Class I/II recall in past 12 months+15

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for mirabegron (oral solid) in the next 90 days

sole-source market · 1 Class I/II recall(s) in 12 months

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA209488
TE code
AB
Approval date
Sep 29, 2022
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingAug 5, 2026
    Zydus Pharmaceuticals (USA) IncCGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Manufacturers of Mirabegron (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
Remedyrepack Inc.MIRABEGRON 25 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.MIRABEGRON 50 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedMIRABEGRON 25 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedMIRABEGRON 50 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.MIRABEGRON 25 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals (USA) Inc.MIRABEGRON 50 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Mirabegron — NDC 70710-1159-09," retrieved September 3, 2026, https://drugdashboards.com/drug/70710115909.

Free to cite with attribution — see how the data is put together.