Drug Information

Product NDC: 81583-100

Proprietary Name: ZTALMY

Non Proprietary Name: ganaxolone

Active Ingredient(s):
  • 50 mg/mL GANAXOLONE

Administration Route(s): ORAL

Dosage Form(s): SUSPENSION

Pharmacy Class(es):
  • GABA A Receptor Positive Modulators [MoA];
  • Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]

Labeler Information

Labeler Name: Marinus Pharmaceuticals, Inc.
FDA Application Number: NDA215904
Marketing Category: NDA
Start Marketing Date:6/6/2022
DEA Schedule:CV

Package Information

No. Package Code Package Description Billing Unit
181583-100-011 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTICML
281583-100-055 BOTTLE, PLASTIC in 1 CARTON (81583-100-05) / 110 mL in 1 BOTTLE, PLASTICML

NDC Record

Field Name Field Value Definition
PRODUCT NDC81583-100The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEZTALMYThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEganaxoloneThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/6/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA215904This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMarinus Pharmaceuticals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEGANAXOLONEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESGABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] 
DEA SCHEDULECVThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 4/12/2024