"0054-9628-57" National Drug Code (NDC)

Sodium Oxybate 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-9628-57
Package Description180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)
Product NDC0054-9628
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSodium Oxybate
Non-Proprietary NameSodium Oxybate
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20230103
Marketing Category NameNDA AUTHORIZED GENERIC
Application NumberNDA021196
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameSODIUM OXYBATE
Strength.5
Strength Unitg/mL
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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