United States · FDA National Drug Code directory

ARISTADA INITIO

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18d
Product NDC
65757-500
Form
INJECTION, SUSPENSION, EXTENDED RELEASE
Composition / generic term
aripiprazole lauroxil
Labeler
Alkermes, Inc.
Marketing category
NDA
Marketing start / end (source format)
20180629
Source listing expiry
20261231

Source-listed ingredients

  • ARIPIPRAZOLE LAUROXIL — 675 mg/2.4mL

These values do not establish equivalence or a dose recommendation.

Packages

  • 1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE · 65757-500-03
  • 1 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGE · 65757-500-04

Source and coverage

Open FDA National Drug Code directory

Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

Browse United States records →