United States· US:65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d
ARISTADA INITIO
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
- ndc1165757-500-03
- ndc1165757500031 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE
- ndc1165757500041 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE
- ndc1165757-500-04
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/c96e974c-dc6a-4171-abfc-5e498e4c1d6d GET /v1/drugs/c96e974c-dc6a-4171-abfc-5e498e4c1d6d?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": "675",
"substance": "ARIPIPRAZOLE LAUROXIL",
"productndc": "65757-500",
"dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/2.4mL",
"application_number": "NDA209830",
"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.