DrugDashboards

Isotretinoin

Isotretinoin · ISOTRETINOIN 10 mg/1 · Capsule · Oral · Actavis Pharma, Inc.

NDC 00591-2433-15 · 3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply. The generic price has held steady around $11.94 per unit over the past year. The brand (Absorica) runs $38.22 per unit 7.7× more. 2 Class II recalls 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)$11.94per EAinvoice-surveyed acquisition cost · Jan 21, 2026
  • Part D plans paid (avg)$4.40per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$3.39per CAPweighted avg manufacturer price $1.9368 · Mar 1, 202428% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00378-6611-93) — 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
$3.51per unit
middle half $3.10$5.04 · 5,068 plans · Apr 1, 2026
Est. net of rebates
≈ $3.51
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
92%of plans cover it
tier 4 · prior auth 49% · 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$30.00May 2021Jan 2026$11.94
21 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$358.08
#90 count
$1074.24

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

Medicaid spend (2025)

$41,938
100 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

15Low risk

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

  • 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 $197.43 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Isotretinoin iPLEDGE Shared System REMS

Regulatory

Application
ANDA205063
TE code
AB2
Approval date
Mar 31, 2021
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJan 12, 2026
    Teva Pharmaceuticals USA, IncSuperpotent and Subpotent
  • Class II · OngoingJan 12, 2026
    Teva Pharmaceuticals USA, IncSuperpotent and Subpotent
  • Class II · OngoingMar 28, 2024
    Teva Pharmaceuticals USA, IncSuperpotent Drug: The 3-month stability result for assay was found to be above specification limit

Manufacturers of Isotretinoin (Capsule)

LabelerStrengthFirst seenLast seen
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 3, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 10 mg/1Jul 15, 2026Sep 3, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 25 mg/1Jul 15, 2026Sep 3, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 20 mg/1Jul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedISOTRETINOIN 20 mg/1Jul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedISOTRETINOIN 30 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.ISOTRETINOIN 20 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.ISOTRETINOIN 10 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.ISOTRETINOIN 30 mg/1Jul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.ISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.ISOTRETINOIN 35 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.ISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.ISOTRETINOIN 25 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.ISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 35 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 25 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedISOTRETINOIN 35 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedISOTRETINOIN 25 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Catalent France Beinheim S.AISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Catalent France Beinheim S.A.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Catalent France Beinheim SAISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Catalent France Beinheim SAISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.ISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.ISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.ISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 24 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 8 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 32 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.ISOTRETINOIN 16 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Isotretinoin — NDC 00591-2433-15," retrieved September 3, 2026, https://drugdashboards.com/drug/00591243315.

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