NDC 0054-9628
N/A
Sodium Oxybate
N/A is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Sodium Oxybate.
| Product ID | 0054-9628_bcef2c95-35e9-464d-9025-652acff769e7 |
| NDC | 0054-9628 |
| Product Type | Human Prescription Drug |
| Proprietary Name | N/A |
| Generic Name | Sodium Oxybate |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2023-01-03 |
| Marketing Category | NDA AUTHORIZED GENERIC / |
| Application Number | NDA021196 |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Substance Name | SODIUM OXYBATE |
| Active Ingredient Strength | 1 g/mL |
| Pharm Classes | Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE] |
| DEA Schedule | CIII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |