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  5. NDC Package Code: 81583-100-05 Ztalmy

NDC Package 81583-100-05 Ztalmy

Ganaxolone Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
81583-100-05
Package Description:
5 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC
Product Code:
81583-100
Proprietary Name:
Ztalmy
Non-Proprietary Name:
Ganaxolone
Substance Name:
Ganaxolone
Usage Information:
ZTALMY is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
11-Digit NDC Billing Format:
81583010005
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2604694 - ganaxolone 50 MG in 1 mL Oral Suspension
  • RxCUI: 2604694 - ganaxolone 50 MG/ML Oral Suspension
  • RxCUI: 2604694 - ganaxolone 50 MG per 1 ML Oral Suspension
  • RxCUI: 2604700 - Ztalmy 50 MG in 1 mL Oral Suspension
  • RxCUI: 2604700 - ganaxolone 50 MG/ML Oral Suspension [Ztalmy]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Marinus Pharmaceuticals, Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GANAXOLONE 50 mg/mL
    • Pharmacologic Class(es):
  • GABA A Receptor Positive Modulators - [MoA] (Mechanism of Action)
  • Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule V (CV) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA215904
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-06-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    81583-100-011 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 81583-100-05?

    The NDC Packaged Code 81583-100-05 is assigned to a package of 5 bottle, plastic in 1 carton / 110 ml in 1 bottle, plastic of Ztalmy, a human prescription drug labeled by Marinus Pharmaceuticals, Inc.. The product's dosage form is suspension and is administered via oral form.

    Is NDC 81583-100 included in the NDC Directory?

    Yes, Ztalmy with product code 81583-100 is active and included in the NDC Directory. The product was first marketed by Marinus Pharmaceuticals, Inc. on June 06, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 81583-100-05?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 81583-100-05?

    The 11-digit format is 81583010005. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-281583-100-055-4-281583-0100-05