aripiprazole lauroxil
aripiprazole lauroxil · ARIPIPRAZOLE LAUROXIL 441 mg/1.6mL · Injection, Suspension, Extended Release · Alkermes, Inc.
NDC 65757-0401-00 · 20 TRAY in 1 CARTON / 15 SYRINGE in 1 TRAY / 1.6 mL in 1 SYRINGE · 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 65757-0401-03) — 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)
sterile injectable · price up 7% YoY
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
- Alkermes, IncUnited Statesanalysis · manufacture
- Sharp Packaging Services, LLCUnited Stateslabel · 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 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $2,987.84 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
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 aripiprazole lauroxil (Injection, Suspension, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alkermes, Inc. | ARIPIPRAZOLE LAUROXIL 1064 mg/3.9mL | Jul 15, 2026 | Sep 3, 2026 |
| Alkermes, Inc. | ARIPIPRAZOLE LAUROXIL 441 mg/1.6mL | Jul 15, 2026 | Sep 3, 2026 |
| Alkermes, Inc. | ARIPIPRAZOLE LAUROXIL 662 mg/2.4mL | Jul 15, 2026 | Sep 3, 2026 |
| Alkermes, Inc. | ARIPIPRAZOLE LAUROXIL 675 mg/2.4mL | Jul 15, 2026 | Sep 3, 2026 |
| Alkermes, Inc. | ARIPIPRAZOLE LAUROXIL 882 mg/3.2mL | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "aripiprazole lauroxil — NDC 65757-0401-00," retrieved September 3, 2026, https://drugdashboards.com/drug/65757040100.
Free to cite with attribution — see how the data is put together.