"13551-001-07" National Drug Code (NDC)

Lumryz 7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
(Avadel CNS Pharmaceuticals, LLC)

NDC Code13551-001-07
Package Description7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
Product NDC13551-001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLumryz
Non-Proprietary NameSodium Oxybate
Dosage FormFOR SUSPENSION, EXTENDED RELEASE
UsageORAL
Start Marketing Date20230501
Marketing Category NameNDA
Application NumberNDA214755
ManufacturerAvadel CNS Pharmaceuticals, LLC
Substance NameSODIUM OXYBATE
Strength4.5
Strength Unitg/1
Pharmacy ClassesCentral Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]
DEA ScheduleCIII

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