DrugDashboards

Nitrofurantoin (monohydrate/macrocrystals)

Nitrofurantoin monohydrate/macrocrystals · NITROFURANTOIN MONOHYDRATE 75 mg/1; NITROFURANTOIN 25 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC

NDC 65162-0478-10 · 100 CAPSULE 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 jumped 35% in a year, to $0.3464 per unit — sharp rises like this often mean supply is already tightening. 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)$0.3464per EAinvoice-surveyed acquisition cost · Nov 19, 2025
  • Medicaid generic ceiling (FUL)$0.3477per CAPweighted avg manufacturer price $0.1682 · Jan 1, 2026100% of what pharmacies pay — higher than 57% of drugs with this benchmark

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$0.5$1.00Oct 2017Nov 2025$0.3464
99 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$10.39
#90 count
$31.17

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

Medicaid spend (2025)

$308,371
23,826 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)

0.0%chance of a new FDA shortage posting for nitrofurantoin monohydrate/macrocrystals (oral solid) in the next 90 days

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
ANDA207372
TE code
Approval date
May 15, 2017
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 Nitrofurantoin monohydrate/macrocrystals (Capsule)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCNITROFURANTOIN MONOHYDRATE 75 mg/1; NITROFURANTOIN 25 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCNITROFURANTOIN MONOHYDRATE 25 mg/1; NITROFURANTOIN 75 mg/1Jul 22, 2026Aug 19, 2026
Amneal Pharmaceuticals LLCNITROFURANTOIN 25 mg/1; NITROFURANTOIN MONOHYDRATE 75 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Nitrofurantoin (monohydrate/macrocrystals) — NDC 65162-0478-10," retrieved September 3, 2026, https://drugdashboards.com/drug/65162047810.

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