DrugDashboards

Claravis

Isotretinoin · ISOTRETINOIN 40 mg/1 · Capsule, Liquid Filled · Oral · Teva Pharmaceuticals USA, Inc.

NDC 00555-1057-56 · 10 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. The price is down 8% over the past year, to $2.18 per unit. A Class II recall hit this product in the past year (Teva Pharmaceuticals USA, Inc). 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.

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)$2.18per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$3.35per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$4.30per CAPweighted avg manufacturer price $2.4591 · Jun 1, 2021197% of what pharmacies pay — higher than 86% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 69238-1176-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$4.28per unit
middle half $3.37$5.24 · 5,250 plans · Apr 1, 2026
Est. net of rebates
≈ $4.28
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
96%of plans cover it
tier 4 · prior auth 47% · 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$5.00$10.00Nov 2013Sep 2026$2.18
154 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$65.55
#90 count
$196.64

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

Medicaid spend (2025)

$303,129
3,295 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

20Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 5 active manufacturers+5
  • 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)

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

4 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 →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $147.71 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Isotretinoin iPLEDGE Shared System REMS

Regulatory

Application
ANDA076135
TE code
AB1
Approval date
Apr 11, 2003
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingApr 6, 2026
    Teva Pharmaceuticals USA, IncFailed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Manufacturers of Isotretinoin (Capsule, Liquid Filled)

LabelerStrengthFirst seenLast seen
Mayne PharmaISOTRETINOIN 30 mg/1Jul 15, 2026Sep 3, 2026
Upsher-Smith Laboratories, LLCISOTRETINOIN 10 mg/1Jul 15, 2026Sep 3, 2026
Upsher-Smith Laboratories, LLCISOTRETINOIN 40 mg/1Jul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCISOTRETINOIN 40 mg/1Aug 5, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCISOTRETINOIN 20 mg/1Aug 5, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCISOTRETINOIN 30 mg/1Aug 5, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCISOTRETINOIN 10 mg/1Aug 5, 2026Sep 2, 2026
Swiss Caps AGISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Swiss Caps AGISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Swiss Caps AGISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Swiss Caps AGISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.ISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.ISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.ISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Mayne PharmaISOTRETINOIN 10 mg/1Jul 15, 2026Aug 31, 2026
Mayne PharmaISOTRETINOIN 20 mg/1Jul 15, 2026Aug 31, 2026
Upsher-Smith Laboratories, LLCISOTRETINOIN 30 mg/1Jul 15, 2026Aug 31, 2026
Upsher-Smith Laboratories, LLCISOTRETINOIN 20 mg/1Jul 15, 2026Aug 31, 2026
Mayne PharmaISOTRETINOIN 40 mg/1Jul 15, 2026Aug 28, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 30 mg/1Jul 15, 2026Jul 29, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 40 mg/1Jul 15, 2026Jul 29, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 20 mg/1Jul 15, 2026Jul 29, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 10 mg/1Jul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Claravis — NDC 00555-1057-56," retrieved September 3, 2026, https://drugdashboards.com/drug/00555105756.

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