DrugDashboards

Timolol Maleate

timolol maleate · TIMOLOL MALEATE 5 mg/mL · Solution/ Drops · Ophthalmic · Rising Pharma Holdings, Inc.

NDC 64980-0514-01 · 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. The generic price is down 15% over the past year, to $0.7316 per mL. The brand (Istalol) runs $79.89 per mL 109× 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)$0.7316per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$3.64per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 24208-0004-03) — 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
$81.59per unit
middle half $81.57$81.61 · 2 plans · Apr 1, 2026
Est. net of rebates
≈ $81.59
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 0%

*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 10 quarters since 2024.

NADAC price per unit

$0$0.5$1.00$1.50Jul 2015Sep 2026$0.7316
134 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$14.20
Reported to Texas DSHS · 2026 annual filing · Rising Pharma Holdings, Inc.

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

Medicaid spend (2025)

$106,682
6,176 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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)

0.2%chance of a new FDA shortage posting for timolol maleate (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
ANDA077259
TE code
AT1
Approval date
Apr 30, 2008
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJul 5, 2025
    FDC LimitedDefective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
  • Class II · OngoingApr 18, 2025
    FDC LimitedDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
  • Class II · OngoingJan 23, 2025
    FDC LimitedDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
  • Class II · OngoingDec 5, 2024
    FDC LimitedDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
  • Class II · OngoingOct 29, 2024
    FDC LimitedDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
  • Class II · OngoingAug 12, 2024
    FDC LimitedDefective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
  • Class II · OngoingJul 18, 2024
    FDC LimitedDefective container; yellow colored spike from cap lodged in the nozzle
  • Class II · TerminatedApr 25, 2024
    FDC LimitedDefective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
  • Class III · TerminatedNov 15, 2019
    Rising Pharmaceuticals, Inc.Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
  • Class III · TerminatedNov 15, 2019
    Rising Pharmaceuticals, Inc.Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

Manufacturers of timolol maleate (Solution/ Drops)

LabelerStrengthFirst seenLast seen
Lifestar Pharma LLCTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 3, 2026
Lifestar Pharma LLCTIMOLOL MALEATE 2.5 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCTIMOLOL MALEATE 2.5 mg/mLJul 15, 2026Sep 3, 2026
A-S Medication SolutionsTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
Bausch & Lomb Americas Inc.TIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
Bausch & Lomb IncorporatedTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
First Nation Group, LLCTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
First Nation Group, LLCTIMOLOL MALEATE 2.5 mg/mLJul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCTIMOLOL MALEATE 3.4 mg/mLJul 15, 2026Sep 2, 2026
Ingenus Pharmaceuticals, LLCTIMOLOL MALEATE 6.8 mg/mLJul 15, 2026Sep 2, 2026
Micro Labs LimitedTIMOLOL MALEATE 6.8 mg/mLJul 15, 2026Sep 2, 2026
NorthStar RxLLCTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
Oceanside PharmaceuticalsTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
Pacific Pharma, Inc.TIMOLOL MALEATE 2.5 mg/mLJul 15, 2026Sep 2, 2026
Pacific Pharma, Inc.TIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.TIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.TIMOLOL MALEATE 2.5 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCTIMOLOL MALEATE 5 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Timolol Maleate — NDC 64980-0514-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64980051401.

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