Drug company (FDA labeler)
Alkermes, Inc.
NDC labeler codes: 13551, 65757
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Aripiprazole lauroxilAristada, Aristada Initio · 5 products
- Olanzapine and samidorphan l-malateLybalvi · 4 products
- Sodium oxybateLumryz, Xyrem · 4 products
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 1, 2023 | NDA214755 | Sodium oxybate LUMRYZ | Alkermes Inc |
| May 28, 2021 | NDA213378 | Olanzapine and samidorphan l-malate LYBALVI | Alkermes Inc |
| June 29, 2018 | NDA209830 | Aripiprazole lauroxil ARISTADA INITIO KIT | Alkermes Inc |
| October 5, 2015 | NDA207533 | Aripiprazole lauroxil ARISTADA | Alkermes Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026