DrugDashboards

Zenatane

Isotretinoin · ISOTRETINOIN 40 mg/1 · Capsule, Gelatin Coated · Oral · Dr. Reddy's Laboratories Limited

NDC 55111-0137-81 · 3 BLISTER PACK in 1 CARTON / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price is down 8% over the past year, to $2.18 per unit. 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)$3.47per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$3.97per unitnegotiated price across 5,127 plans — before rebates · Apr 1, 2026
  • 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
$3.97per unit
middle half $3.07$4.83 · 5,127 plans · Apr 1, 2026
Est. net of rebates
≈ $3.97
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
93%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
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)

$2.5M
20,981 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

10Low risk

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

  • 3 active manufacturers+10

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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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 $157.58 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Isotretinoin iPLEDGE Shared System REMS

Regulatory

Application
ANDA202099
TE code
AB1
Approval date
Mar 25, 2013
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMay 22, 2017
    Dr. Reddy's Laboratories, Inc.Failed Dissolution Specifications: out of specification results observed for low dissolution.
  • Class II · TerminatedMay 22, 2017
    Dr. Reddy's Laboratories, Inc.Failed Dissolution Specifications: out of specification results observed for low dissolution.
  • Class II · TerminatedMay 22, 2017
    Dr. Reddy's Laboratories, Inc.Failed Dissolution Specifications: out of specification results observed for low dissolution.
  • Class II · TerminatedMay 22, 2017
    Dr. Reddy's Laboratories, Inc.Failed Dissolution Specifications: out of specification results observed for low dissolution.
  • Class III · TerminatedFeb 15, 2017
    Dr. Reddy's Laboratories, Inc.Failed dissolution specifications - low dissolution results at S3 stage.
  • Class III · TerminatedFeb 15, 2017
    Dr. Reddy's Laboratories, Inc.Failed dissolution specifications - low dissolution results at S3 stage.
  • Class III · TerminatedFeb 15, 2017
    Dr. Reddy's Laboratories, Inc.Failed dissolution specifications - low dissolution results at S3 stage.
  • Class III · TerminatedAug 29, 2016
    Dr. Reddy's Laboratories, Inc.Failed Dissolution Specifications

Manufacturers of Isotretinoin (Capsule, Gelatin Coated)

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories LimitedISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
JG Pharma Inc.ISOTRETINOIN 40 mg/1Jul 15, 2026Sep 2, 2026
JG Pharma Inc.ISOTRETINOIN 20 mg/1Jul 15, 2026Sep 2, 2026
JG Pharma Inc.ISOTRETINOIN 30 mg/1Jul 15, 2026Sep 2, 2026
JG Pharma Inc.ISOTRETINOIN 10 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Zenatane — NDC 55111-0137-81," retrieved September 3, 2026, https://drugdashboards.com/drug/55111013781.

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