The short version
10 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Isotretinoin
Isotretinoin · ISOTRETINOIN 20 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC 69238-1255-03 · 3 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK · ANDA · View full market →
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 →
Where it's made
- Amneal Pharmaceuticals of New York, LLCUnited Statesanalysis · label · manufacture · pack
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
- Costs ≥ $950/fill · avg $197.43 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Isotretinoin iPLEDGE Shared System REMS
Regulatory
- Application
- ANDA216097
- TE code
- —
- Approval date
- Oct 7, 2025
- Patents / exclusivity
- None on file
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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 25 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Lifesciences Limited | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Lifesciences Limited | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| Actavis Pharma, Inc. | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | ISOTRETINOIN 35 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | ISOTRETINOIN 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Actavis Pharma, Inc. | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 35 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ISOTRETINOIN 35 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ISOTRETINOIN 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent France Beinheim S.A | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent France Beinheim S.A. | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent France Beinheim SA | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent France Beinheim SA | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | ISOTRETINOIN 30 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | ISOTRETINOIN 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | ISOTRETINOIN 20 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | ISOTRETINOIN 40 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 24 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 8 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 32 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | ISOTRETINOIN 16 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Isotretinoin — NDC 69238-1255-03," retrieved September 3, 2026, https://drugdashboards.com/drug/69238125503.
Free to cite with attribution — see how the data is put together.