DrugDashboards

Bepotastine Besilate

Bepotastine Besilate · BEPOTASTINE BESILATE 15 mg/mL · Solution · Ophthalmic · Somerset Therapeutics, LLC

NDC 70069-0711-01 · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price is down 24% over the past year, to $11.25 per mL. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. 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)$11.25per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$21.70per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

$0$10.00$20.00$30.00Feb 2025Sep 2026$11.25
20 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$187.66
Reported to Texas DSHS · 2026 annual filing · Somerset Therapeutics, LLC

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$25,644
318 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

38● Elevated risk

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

  • 1 active manufacturer+30
  • price down 23% year over year+8

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 bepotastine besilate (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

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
ANDA217770
TE code
AT
Approval date
Aug 14, 2024
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Bepotastine Besilate (Solution)

LabelerStrengthFirst seenLast seen
Somerset Therapeutics, LLCBEPOTASTINE BESILATE 15 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Bepotastine Besilate — NDC 70069-0711-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70069071101.

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