DrugDashboards

Isotretinoin

Isotretinoin · ISOTRETINOIN 20 mg/1 · Capsule · Catalent France Beinheim S.A

NDC 64566-0003-01 · 1 BAG in 1 CARTON / 18000 CAPSULE in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00378-6612-93) — 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ⓘ
$3.60per unit
middle half $2.83–$4.95 · 5,068 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $3.60
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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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 $173.93 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Isotretinoin iPLEDGE Shared System REMS

Regulatory

Application
—
TE code
—
Approval date
—
Patents / exclusivity
—

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

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 64566-0003-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64566000301.

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