| NDC Code | 13551-002-07 |
|---|
| Package Description | 7 PACKET in 1 CARTON (13551-002-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
|---|
| Product NDC | 13551-002 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Lumryz |
|---|
| Non-Proprietary Name | Sodium Oxybate |
|---|
| Dosage Form | FOR SUSPENSION, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20230501 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA214755 |
|---|
| Manufacturer | Avadel CNS Pharmaceuticals, LLC |
|---|
| Substance Name | SODIUM OXYBATE |
|---|
| Strength | 6 |
|---|
| Strength Unit | g/1 |
|---|
| Pharmacy Classes | Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE] |
|---|
| DEA Schedule | CIII |
|---|