NDCFind

Ztalmy 81583-0100-01

Generic: Ganaxolone

Package NDC

81583-0100-01

Product NDC: 81583-0100

Manufacturer
Immedica Pharma Us Inc
Dosage Form
Suspension
Route
Oral
Product Type
Human Prescription Drug
DEA Schedule
Schedule CV
Marketing Start
June 6, 2022
Listing Expires
December 31, 2026
Application
NDA215904

Active Ingredients

IngredientStrength
Ganaxolone50 mg/mL

Drug Class

Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]GABA A Receptor Positive Modulators [MoA]Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]

Selected Package

81583-0100-01Selected

1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC