DrugDashboards

Bepotastine Besilate

Bepotastine Besilate · BEPOTASTINE BESILATE 15 mg/mL · Solution/ Drops · Ophthalmic · Mylan Pharmaceuticals Inc.

NDC 00378-7055-35 · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The generic price is down 24% over the past year, to $11.25 per mL. The brand (Bepreve) runs $55.94 per mL 5.7× more. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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
  • Part D point of sale (median)$21.51per unitnegotiated price across 923 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$21.51per unit
middle half $21.07$21.94 · 923 plans · Apr 1, 2026
Est. net of rebates
≈ $21.51
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
17%of plans cover it
tier 4 · prior auth 0% · step therapy 3% · qty limit 4%

*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$20.00$40.00Aug 2021Sep 2026$11.25
62 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$208.52
Reported to Texas DSHS · 2026 annual filing · Mylan Pharmaceuticals Inc.

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

Medicaid spend (2025)

$199,074
2,531 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

18Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10
  • 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 →

Regulatory

Application
ANDA206220
TE code
AT
Approval date
Mar 18, 2019
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/ Drops)

LabelerStrengthFirst seenLast seen
Bausch & Lomb Americas Inc.BEPOTASTINE BESYLATE 15 mg/mLJul 15, 2026Sep 2, 2026
Bausch & Lomb IncorporatedBEPOTASTINE BESILATE 15 mg/mLJul 15, 2026Sep 2, 2026
Bausch & Lomb IncorporatedBEPOTASTINE BESYLATE 15 mg/mLJul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.BEPOTASTINE BESILATE 15 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Bepotastine Besilate — NDC 00378-7055-35," retrieved September 3, 2026, https://drugdashboards.com/drug/00378705535.

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