"81583-100-05" National Drug Code (NDC)

Ztalmy 5 BOTTLE, PLASTIC in 1 CARTON (81583-100-05) / 110 mL in 1 BOTTLE, PLASTIC
(Marinus Pharmaceuticals, Inc.)

NDC Code81583-100-05
Package Description5 BOTTLE, PLASTIC in 1 CARTON (81583-100-05) / 110 mL in 1 BOTTLE, PLASTIC
Product NDC81583-100
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZtalmy
Non-Proprietary NameGanaxolone
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20220606
Marketing Category NameNDA
Application NumberNDA215904
ManufacturerMarinus Pharmaceuticals, Inc.
Substance NameGANAXOLONE
Strength50
Strength Unitmg/mL
Pharmacy ClassesGABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
DEA ScheduleCV

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