"65162-065-87" National Drug Code (NDC)

Sodium Oxybate 1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE
(Amneal Pharmaceuticals LLC)

NDC Code65162-065-87
Package Description1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE
Product NDC65162-065
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSodium Oxybate
Non-Proprietary NameSodium Oxybate
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20250912
Marketing Category NameANDA
Application NumberANDA203631
ManufacturerAmneal Pharmaceuticals LLC
Substance NameSODIUM OXYBATE
Strength500
Strength Unitmg/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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