FDA NDC Directory · JSON-LD · Markdown
NDC 13551-003 · HUMAN PRESCRIPTION DRUG · FOR SUSPENSION, EXTENDED RELEASE
| Generic name | sodium oxybate |
|---|---|
| Labeler / Manufacturer | Avadel CNS Pharmaceuticals, LLC |
| Marketing category | New Drug Application (innovator) · App NDA214755 |
| Dosage form / route | FOR SUSPENSION, EXTENDED RELEASE · ORAL |
| Active ingredients | SODIUM OXYBATE (7.5 g/1) |
| Marketing started | 20230501 |
| Package count | 2 |
Source: openFDA. Public-domain (CC0).