DrugDashboards

Vytorin

ezetimibe and simvastatin · EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1 · Tablet · Oral · Organon LLC

NDC 78206-0177-01 · 30 TABLET in 1 BOTTLE · NDA · View full market →

The short version

9 companies list this market (plus 2 repackagers, which add no supply) — a reasonable cushion if one runs into trouble. Generic versions run $0.3114 per unit — 44× cheaper. 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.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
  • CMS NADAC — latest price vs the price in effect ~12 months earlier
  • FDA drug shortages and enforcement reports (openFDA)
  • FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model
Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

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 weekly file (pharmacy acquisition, per unit)
  • CMS Part B ASP quarterly payment limit file + NDC–HCPCS crosswalk
  • CMS Maximum Fair Prices (IRA negotiated), matched on the NDC-9
  • CMS Part D Spending by Drug (annual, name-matched, gross incl. dispensing fee)
  • CMS Part D plan formulary/pricing files (SPUF): point-of-sale price across plans
  • VA FSS / Big4 federal contract prices (per package; per unit when the package is a count above 1)
  • CMS Federal Upper Limits + weighted AMP for the multiple-source drug group (monthly)
  • Texas DSHS annual WAC catalog, then Texas/California increase filings (per package)
Method

Each rung is the newest figure for this NDC from one price system, shown with its own unit — units differ, so compare a rung over time, not rung against rung. Part B is the file's payment limit (typically ASP+6%, WAC+3% for new drugs; sequestration is applied at claim level); when the NDC maps to several HCPCS codes the lowest code is shown and the count noted. Part D average is shown only on an exact brand-name match or a generic name with a single CMS row. FSS keeps the lowest active contract price, Big4 first, and skips 1¢ placeholders. The FUL belongs to the whole multiple-source group, so a brand NDC shows its generic group's ceiling. WAC is the Texas catalog's current list price, else the newest increase filing already in effect. To check a rung: open the named CMS/VA/state file for the date shown and find this NDC.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$13.15per EAinvoice-surveyed acquisition cost · Jan 1, 2025
  • Part D plans paid (avg)$12.40per dosage unitCMS row "Vytorin", matched by brand name — gross incl. dispensing fee, before rebates · 2024
  • Part D point of sale (median)$14.20per unitnegotiated price across 2 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$9.93per unitOrganon LLC · Jan 1, 202675% of what pharmacies pay — a deeper discount than 65% of drugs with this benchmark
  • Medicaid ceiling, generic group (FUL)$0.4476per TABweighted avg manufacturer price $0.2288 · May 1, 20263% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark
  • List price (WAC, as filed)$432.98per packageTexas DSHS annual report · Organon LLC · 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ⓘ
$14.20per unit
middle half $14.20–$14.20 · 2 plans · Apr 1, 2026
Est. net of rebatesⓘ
$8.52–$10.65
brand drug — est. 25–40% rebate off the price at left
Coverage & restrictions
<1%of plans cover it
tier 1 · prior auth 0% · step therapy 100% · qty limit 100%

*No drug-level rebate is public — the estimate applies a 25–40% brand range derived from MedPAC's program-wide aggregates to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

ⓘ How this was built
Data sources
  • CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
  • CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
  • CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)
Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

$0$5.00$10.00$15.00Jul 2024Jan 2025$13.15
4 price points · per EA · last surveyed Invalid Date · dashed = generic group's manufacturer avg (WAMP)Source: CMS NADAC — monthly means to Nov 2024, weekly file after

Estimated fill cost

#30 count
$394.57
#90 count
$1183.72

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

Supply fragility

0● Low risk

Nothing here is signaling trouble: several labelers (repackagers excluded), 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 4, 2026

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers excluded via DailyMed SPL roles
  • FDA drug shortages and enforcement reports (openFDA)
  • CMS NADAC weekly file — price now vs the price in effect a year ago
Method

Fragility v1 adds fixed points per condition for this NDC's molecule × dosage form: active labelers minus repackagers (1 → +30, 2 → +20, 3 → +10, 4–5 → +5; unknown count → 0); shortage (this NDC listed Current +25, another presentation of the same molecule/form +15, a resolution within 12 months +8); Class I/II recalls in 12 months (this NDC +15, same molecule/form +8); NADAC down 40%+ year over year +15 or 20%+ +8 (a Medicare-negotiated price cut also trips this); sterile injectable form or intravenous route +10; a to-be-discontinued FDA listing +10; capped at 100. Every point shows as a line above. To check: count the molecule's labelers in the NDC Directory, then look it up in FDA's shortage list, openFDA enforcement, and two NADAC files a year apart.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for ezetimibe and simvastatin (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months)

For scale: the typical drug’s chance is about 0.1% — this one is less than 1.5× that, which we treat as ordinary.

Backtested statistical model over the whole market, not this package alone. Model details →

ⓘ How this was built
Data sources
  • FDA NDC Directory labeler counts, CMS NADAC price trend, openFDA shortages and enforcement, FDA inspection classifications, Wayback archive of FDA's shortage list (labels)
Method

A logistic regression over molecule × dosage-form markets, trained on a monthly grid of historical dates since 2019 with labels equal to whether a new FDA shortage posting appeared within the following 90 days; eight features knowable on each date (labeler count, sole-source flag, NADAC year-over-year change, Class I/II recalls, injectable form, discontinuation filings, open shortage episodes, recent OAI inspection). The probability shown is the model's output for today's feature values; the reasons are the features pushing this market's probability up, listed only when the feature actually holds here. Held-out performance and coefficients are on the fragility page.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Regulatory

Application
NDA021687
TE code
AB
Approval date
Jul 23, 2004
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application NDA021687, edition retrieved 2026-08-24
Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Shortage history

ⓘ How this was built
Data sources
  • FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
  • Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
  • DrugDashboards Kaplan–Meier duration curves and conditional duration model
Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Not on FDA's current shortage list. Archived episodes below.

Archived episodes (FDA list history via Wayback, 2019+)
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 10 mg (NDC 45963-565-08) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 10 mg (NDC 45963-565-30) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 20 mg (NDC 45963-566-08) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 20 mg (NDC 45963-566-30) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 40 mg (NDC 45963-567-08) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 40 mg (NDC 45963-567-30) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 80 mg (NDC 45963-568-08) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025
  • Planned discontinuation — Teva Pharmaceuticals USA, Inc., EZETIMIBE AND SIMVASTATIN, Tablet, 10 mg; 80 mg (NDC 45963-568-30) (listed as “Ezetimibe; Simvastatin Tablet”)Jan 6, 2025 → last seen Dec 16, 2025

Recalls (this NDC)

ⓘ How this was built
Data sources
  • FDA drug enforcement reports via openFDA
Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No enforcement reports list this package NDC.

Labelers of ezetimibe and simvastatin (Tablet)

11 labelers active in the last 30 days, of which 2 are repackagers; 0not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built
Data sources
  • FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
  • DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)
Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

LabelerStrengthsFirst seenLast seen
A-S Medication SolutionsrepackagerEZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1Jul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals NY LLCEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.repackagerEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
MSD International GmbH (Singapore Branch)EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Northstar Rx LlcEZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 80 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Organon LLCEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Organon Pharma (Uk) LimitedEZETIMIBE 10 mg/1; SIMVASTATIN 10 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 20 mg/1; EZETIMIBE 10 mg/1; SIMVASTATIN 40 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Vytorin — NDC 78206-0177-01," retrieved September 4, 2026, https://drugdashboards.com/drug/78206017701.

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