NDC product
sodium oxybate
NDC 0054-9628 · Hikma Pharmaceuticals USA Inc.
Key facts
| Product NDC | 0054-9628 |
|---|---|
| Proprietary name | sodium oxybate |
| Nonproprietary name | sodium oxybate |
| Substances | SODIUM OXYBATE |
| Dosage form | SOLUTION |
| Route | ORAL |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA AUTHORIZED GENERIC |
| Application number | NDA021196 |
| DEA schedule | CIII |
| Pharmacologic classes | Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE] |
| Marketing start | Jan 3, 2023 |
| Listing certified through | Dec 31, 2026 |
At a glance
- 1–9 Package NDCs
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About National Drug Codes (NDC)
The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.
Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date: