isotretinoin
isotretinoin · ISOTRETINOIN 40 mg/1 · Capsule, Liquid Filled · Swiss Caps AG
NDC 65655-0006-01 · 2 POUCH in 1 CARTON / 5000 CAPSULE, LIQUID FILLED in 1 POUCH · 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 69238-1176-03) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
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.
*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)
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, Liquid Filled)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Mayne Pharma | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Upsher-Smith Laboratories, LLC | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Upsher-Smith Laboratories, LLC | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Amneal Pharmaceuticals LLC | ISOTRETINOIN 40 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | ISOTRETINOIN 20 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | ISOTRETINOIN 30 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | ISOTRETINOIN 10 mg/1 | Aug 5, 2026 | Sep 2, 2026 |
| Swiss Caps AG | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swiss Caps AG | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swiss Caps AG | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Swiss Caps AG | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mayne Pharma | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Mayne Pharma | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Upsher-Smith Laboratories, LLC | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Upsher-Smith Laboratories, LLC | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Aug 31, 2026 |
| Mayne Pharma | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Aug 28, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Jul 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "isotretinoin — NDC 65655-0006-01," retrieved September 3, 2026, https://drugdashboards.com/drug/65655000601.
Free to cite with attribution — see how the data is put together.