Data / Drug companies / Alkermes, Inc.
Alkermes, Inc.: 25 products in the FDA NDC directory, labeler code 65757
Alkermes, Inc. (labeler code 65757) lists 25 products in the FDA National Drug Code Directory, covering 3 finished drugs by generic name. By type: 14 drugs for further processing, 11 prescription drugs. Its main marketing category is drugs for further processing. The newest product started marketing on September 20, 2021.
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- Labeler code
- 65757
- Products in commercial distribution
- 25
- Packages
- 34
- Finished drugs by generic name
- 3
- Prescription products
- 11
- Over the counter products
- 0
- Flagged as original packager
- 11 of 11 products that carry the flag
- Started marketing in the last 12 months
- 0
- Earliest marketing start
- October 29, 2003
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Drugs for further processing | 14 | 56% |
| New drug applications (NDA) | 11 | 44% |
Products by type
| Type | Products | Share |
|---|---|---|
| Drugs for further processing | 14 | 56% |
| Prescription drugs | 11 | 44% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Aripiprazole lauroxil | 5 | 1 |
| Olanzapine and samidorphan l-malate | 4 | 1 |
| Naltrexone | 2 | 2 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, suspension, extended release | 10 | 40% |
| Tablet, film coated | 8 | 32% |
| Injection, suspension | 5 | 20% |
| Kit | 2 | 8% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Atypical Antipsychotic | 9 |
| Opioid Antagonist | 4 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Lybalvi | 65757-654 | Tablet, film coated | New drug applications (NDA) | September 20, 2021 |
| Lybalvi | 65757-653 | Tablet, film coated | New drug applications (NDA) | September 20, 2021 |
| Lybalvi | 65757-652 | Tablet, film coated | New drug applications (NDA) | September 20, 2021 |
| Lybalvi | 65757-651 | Tablet, film coated | New drug applications (NDA) | September 20, 2021 |
| Olanzapine and samidorphan l-malate | 65757-654 | Tablet, film coated | Drugs for further processing | May 28, 2021 |
| Olanzapine and samidorphan l-malate | 65757-653 | Tablet, film coated | Drugs for further processing | May 28, 2021 |
| Olanzapine and samidorphan l-malate | 65757-652 | Tablet, film coated | Drugs for further processing | May 28, 2021 |
| Olanzapine and samidorphan l-malate | 65757-651 | Tablet, film coated | Drugs for further processing | May 28, 2021 |
| Aristada initio | 65757-500 | Injection, suspension, extended release | New drug applications (NDA) | June 29, 2018 |
| Aripiprazole lauroxil | 65757-500 | Injection, suspension, extended release | Drugs for further processing | June 29, 2018 |
| Aripiprazole lauroxil | 65757-404 | Injection, suspension, extended release | Drugs for further processing | June 5, 2017 |
| Aristada | 65757-404 | Injection, suspension, extended release | New drug applications (NDA) | June 5, 2017 |
| Aripiprazole lauroxil | 65757-403 | Injection, suspension, extended release | Drugs for further processing | October 5, 2015 |
| Aristada | 65757-403 | Injection, suspension, extended release | New drug applications (NDA) | October 5, 2015 |
| Aripiprazole lauroxil | 65757-402 | Injection, suspension, extended release | Drugs for further processing | October 5, 2015 |
| Aristada | 65757-402 | Injection, suspension, extended release | New drug applications (NDA) | October 5, 2015 |
| Aristada | 65757-401 | Injection, suspension, extended release | New drug applications (NDA) | October 5, 2015 |
| Aripiprazole lauroxil | 65757-401 | Injection, suspension, extended release | Drugs for further processing | October 5, 2015 |
| Vivitrol | 65757-301 | Kit | New drug applications (NDA) | June 13, 2006 |
| Vivitrol | 65757-300 | Kit | New drug applications (NDA) | June 13, 2006 |
| Naltrexone | 65757-360 | Injection, suspension | Drugs for further processing | April 13, 2006 |
| Risperidone | 65757-728 | Injection, suspension | Drugs for further processing | October 29, 2003 |
| Risperidone | 65757-727 | Injection, suspension | Drugs for further processing | October 29, 2003 |
| Risperidone | 65757-726 | Injection, suspension | Drugs for further processing | October 29, 2003 |
| Risperidone | 65757-725 | Injection, suspension | Drugs for further processing | October 29, 2003 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.