DrugDashboards

Amnesteem

isotretinoin · ISOTRETINOIN 40 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.

NDC 00378-6614-93 · 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 is down 8% over the past year, to $2.18 per unit. The brand (Absorica) runs $38.22 per unit — 7.7× more. A Class II recall hit this product in the past year (Mylan Pharmaceuticals 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)$3.24per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$4.46per unitnegotiated price across 5,068 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$2.86per unitMylan Pharmaceuticals, Inc. · Jan 1, 2023131% of what pharmacies pay — higher than 62% of drugs with this benchmark
  • 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 →
ⓘ 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ⓘ
$4.46per unit
middle half $3.35–$6.80 · 5,068 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $4.46
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$5.00$10.00Nov 2013Sep 2026$2.18
151 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)

$1.3M
8,850 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

15● Low 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 · median tier 4 across plans
  • Costs ≥ $950/fill · avg $145.80 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Isotretinoin iPLEDGE Shared System REMS

Regulatory

Application
ANDA075945
TE code
AB1
Approval date
Nov 8, 2002
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingFeb 24, 2026
    MYLAN PHARMACEUTICALS INC — Failed Dissolution Specifications

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, "Amnesteem — NDC 00378-6614-93," retrieved September 3, 2026, https://drugdashboards.com/drug/00378661493.

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