DrugDashboards

Atropine Sulfate

Atropine Sulfate Monohydrate · ATROPINE SULFATE 10 mg/mL · Solution/ Drops · Ophthalmic · Somerset Therapeutics, LLC

NDC 70069-0716-01 · 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 has held steady around $11.61 per mL over the past year. 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)$11.61per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$4.08per 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$5.00$10.00$15.00Aug 2024Sep 2026$11.61
26 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$43.75
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)

$1,360
35 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated 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

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 atropine sulfate monohydrate (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 1% YoY

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
ANDA217791
TE code
AT2
Approval date
Apr 29, 2024
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedDec 16, 2024
    SOMERSET THERAPEUTICS LLCFailed Impurities/Degradation Specifications

Manufacturers of Atropine Sulfate Monohydrate (Solution/ Drops)

LabelerStrengthFirst seenLast seen
Somerset Therapeutics, LLCATROPINE SULFATE 10 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Atropine Sulfate — NDC 70069-0716-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70069071601.

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