Active ingredient
Aripiprazole Lauroxil
5 finished FDA listings contain Aripiprazole Lauroxil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ARIPIPRAZOLE LAUROXIL
- Dosage forms
- Injection, Suspension, Extended Release
- Routes
- Intramuscular
- Manufacturers / labelers
- 1
- Strengths listed
- 1064 mg/3.9ml · 441 mg/1.6ml · 662 mg/2.4ml · 675 mg/2.4ml · 882 mg/3.2ml
- Brand names in FDA listings
- Aristada, Aristada Initio
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1673265
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 207533 | ALKERMES INC | 2015-10-05 | 4 |
| NDA 209830 | ALKERMES INC | 2018-06-29 | 1 |
Official labeling on DailyMed
- ARISTADA (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.] · version 32 · 2025-02-10
- ARISTADA INITIO (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.] · version 16 · 2025-02-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.