81583-100 : Ztalmy 50 mg/ml Oral Suspension


NDC81583-100
Labeler: Marinus Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Ztalmy
Dosage Form: Oral Suspension
Application #: NDA215904
Rev. Date: 
CSA Schedule: CV (US) [1]


[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 81583-100-01: 1 BOTTLE, PLASTIC IN 1 CARTON (81583‑100‑01) > 110 ML IN 1 BOTTLE, PLASTIC
  • 81583-100-05: 5 BOTTLE, PLASTIC IN 1 CARTON (81583‑100‑05) > 110 ML IN 1 BOTTLE, PLASTIC

Active Ingredients:

  • Ganaxolone

Dosage Strength:

  • 50 mg/mL

Pharmaceutical Classes:

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

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.