DrugDashboards

Clonidine transdermal system

Clonidine · CLONIDINE .3 mg/d · Patch · Transdermal · Actavis Pharma, Inc.

NDC 00591-3510-04 · 4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 7 d in 1 PATCH · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price has held steady around $12.05 per unit over the past year. 3 Class II recalls hit this product in the past year (Teva Pharmaceuticals USA, Inc). 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)$12.05per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$18.68per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$22.01per unitnegotiated price across 5,495 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$19.05per unitAvKare, LLC · Jun 15, 2023158% of what pharmacies pay — higher than 67% of drugs with this benchmark
  • Medicaid generic ceiling (FUL)$12.05per TDPweighted avg manufacturer price $6.8296 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

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
$22.01per unit
middle half $17.92$30.59 · 5,495 plans · Apr 1, 2026
Est. net of rebates
≈ $22.01
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 46%

*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$20.00$40.00Jun 2014Sep 2026$12.05
148 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

WAC per package, as filed
$247.56
Reported to Texas DSHS · 2026 annual filing · Actavis Pharma, Inc.

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

Medicaid spend (2025)

$296,728
3,585 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

35Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 2 active manufacturers+20
  • Class I/II recall in past 12 months+15

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 clonidine (other) in the next 90 days

3 Class I/II recall(s) in 12 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 →

Regulatory

Application
ANDA090873
TE code
AB
Approval date
May 6, 2014
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingMar 19, 2026
    Teva Pharmaceuticals USA, IncCGMP Deviations: use of an unapproved raw material
  • Class II · OngoingMar 19, 2026
    Teva Pharmaceuticals USA, IncCGMP Deviations: use of an unapproved raw material
  • Class II · OngoingMar 19, 2026
    Teva Pharmaceuticals USA, IncCGMP Deviations: use of an unapproved raw material
  • Class III · TerminatedOct 28, 2021
    Teva Pharmaceuticals USAFailed Impurities/Degradation Specifications

Manufacturers of Clonidine (Patch)

LabelerStrengthFirst seenLast seen
Actavis Pharma, Inc.CLONIDINE .1 mg/dJul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.CLONIDINE .2 mg/dJul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.CLONIDINE .3 mg/dJul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLONIDINE .1 mg/dJul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLONIDINE .2 mg/dJul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.CLONIDINE .3 mg/dJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Clonidine transdermal system — NDC 00591-3510-04," retrieved September 3, 2026, https://drugdashboards.com/drug/00591351004.

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