United States· US:65757-403_3d951a36-1e73-4f84-8ebf-4d556d81a086

ARISTADA

A medicinal product containing aripiprazole lauroxil, registered in United States by Alkermes, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedARISTADAATC—REGISTER NO.US:65757-403_3d951a36…PACKS LISTED4CHECKEDSeptember 27, 2026

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

  • ndc11
    65757-403-03
  • ndc11
    65757-403-04
  • ndc11
    6575740303
    1 SYRINGE in 1 CARTON (65757-403-03) / 3.2 mL in 1 SYRINGE
  • ndc11
    6575740304
    1 SYRINGE in 1 CARTON (65757-403-04) / 3.2 mL in 1 SYRINGE

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/dd6e2069-5e3b-4164-8959-672c5d895d71
GET /v1/drugs/dd6e2069-5e3b-4164-8959-672c5d895d71?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": "882",
  "substance": "ARIPIPRAZOLE LAUROXIL",
  "productndc": "65757-403",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/3.2mL",
  "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.