Quick answers
- What is Aristada Initio?
- Aristada Initio is a brand name of Aripiprazole lauroxil, a prescription medicine. The FDA NDC Directory lists 1 Aristada Initio product in 1 strength and form.
- Who makes Aristada Initio?
- Alkermes Inc holds the FDA application for Aristada Initio (NDA209830, approved June 29, 2018).
- Is there a generic or store brand of Aristada Initio?
- Other products of Aripiprazole lauroxil are listed with the FDA, but none in exactly the same strength and form as a Aristada Initio product.
- What do pharmacies pay for Aristada Initio?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Aristada Initio strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Aristada Initio been recalled?
- No recall linked to Aristada Initio products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Aristada Initio is
Each Aristada Initio product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Aripiprazole lauroxil · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| aripiprazole lauroxil 675 mg/2.4 mL injection, suspension, extended release (intramuscular) | Aristada Initio | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Aripiprazole lauroxil →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA209830 | Alkermes Inc | June 29, 2018 | 1 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| aripiprazole lauroxil 675 mg/2.4 mL injection, suspension, extended release | Brand: Aristada Initio | $1,026.91 per mL |
NADAC list of November 4, 2026; these prices took effect on January 1, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Aristada Initio
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Aristada Initio products.
- Alkermes, Inc.1 product
Recalls
No recall linked to Aristada Initio products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.