NDC Code | 13551-003-07 |
Package Description | 7 PACKET in 1 CARTON (13551-003-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
Product NDC | 13551-003 |
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 | 7.5 |
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 |