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 8 mg/1 · Capsule · Oral · Sun Pharmaceutical Industries, Inc.
NDC 10631-0002-31 · 3 BLISTER PACK in 1 BOX / 10 CAPSULE in 1 BLISTER PACK · NDA · View full market →
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.
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.
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.
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 3 quarters since 2024.
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Not scored — fragility is computed for NADAC-priced NDCs.
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 →
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
| Type | Number / code | Expires |
|---|---|---|
| patent | 9700535 | Aug 4, 2035 |
| patent | 9700535 | Aug 4, 2035 |
| patent | 9700535 | Aug 4, 2035 |
| patent | 9700535 | Aug 4, 2035 |
| patent | 9700535 | Aug 4, 2035 |
| patent | 9700535 | Aug 4, 2035 |
| patent | 9750711 | May 29, 2035 |
| patent | 9750711 | May 29, 2035 |
| patent | 9750711 | May 29, 2035 |
| patent | 9750711 | May 29, 2035 |
| patent | 9750711 | May 29, 2035 |
| patent | 9750711 | May 29, 2035 |
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| 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.
DrugDashboards, "Absorica LD — NDC 10631-0002-31," retrieved September 3, 2026, https://drugdashboards.com/drug/10631000231.
Free to cite with attribution — see how the data is put together.