United States· US:65757-401_3d951a36-1e73-4f84-8ebf-4d556d81a086
ARISTADA
A medicinal product containing aripiprazole lauroxil, registered in United States by Alkermes, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ARIPIPRAZOLE LAUROXIL
- Manufacturer
- Alkermes, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1165757401031 SYRINGE in 1 CARTON (65757-401-03) / 1.6 mL in 1 SYRINGE
- ndc1165757401041 SYRINGE in 1 CARTON (65757-401-04) / 1.6 mL in 1 SYRINGE
- ndc1165757-401-03
- ndc1165757-401-04
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/c9bdbec1-8805-449e-a6a5-76a3275b162b GET /v1/drugs/c9bdbec1-8805-449e-a6a5-76a3275b162b?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR",
"source": "ndc",
"strength": "441",
"substance": "ARIPIPRAZOLE LAUROXIL",
"productndc": "65757-401",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1.6mL",
"application_number": "NDA207533",
"marketing_category": "NDA"
}See everything about aripiprazole lauroxil.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.