DrugDashboards

gynazole 1

butoconazole nitrate · BUTOCONAZOLE NITRATE 100 mg/5g · Cream · Vaginal · Padagis Israel Pharmaceuticals Ltd

NDC 45802-0396-01 · 1 TUBE, WITH APPLICATOR in 1 CARTON / 5.8 g in 1 TUBE, WITH APPLICATOR · 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 $23.34 per gram over the past year. 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)$23.34per GMinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$24.24per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$21.43per unitnegotiated price across 8 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$89.69per package of 5GMPadagis Sourcing Solutions LLC · Oct 1, 2018

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
$21.43per unit
middle half $21.43$21.43 · 8 plans · Apr 1, 2026
Est. net of rebates
≈ $21.43
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 4 · 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$10.00$20.00$30.00Aug 2015Sep 2026$23.34
41 price points · per GMSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$118.99
Reported to Texas DSHS · 2025 annual filing · Padagis Israel Pharmaceuticals Ltd

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

Medicaid spend (2025)

$127,712
1,064 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)

0.1%chance of a new FDA shortage posting for butoconazole nitrate (other) in the next 90 days

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
ANDA200923
TE code
Approval date
May 18, 2012
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingSep 28, 2023
    Padagis US LLCIncorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

Manufacturers of butoconazole nitrate (Cream)

LabelerStrengthFirst seenLast seen
Padagis Israel Pharmaceuticals LtdBUTOCONAZOLE NITRATE 100 mg/5gJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "gynazole 1 — NDC 45802-0396-01," retrieved September 3, 2026, https://drugdashboards.com/drug/45802039601.

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