Ztalmy Suspension
NDC Package 81583-100-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ztalmy (ganaxolone) suspension is 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. This formulation utilizes a suspension delivery system. Marketed by Immedica Pharma Us Inc, this product is identified by NDC 81583-100 and is authorized under FDA application NDA215904.

Identification & Billing

NDC Package Code
81583-100-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC
Product Code
81583-100
11-Digit Billing Format
81583010001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ztalmy
Non-Proprietary Name
Ganaxolone
Substance Name
Ganaxolone
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GANAXOLONE 50 mg/mL
Pharmacologic Class
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.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Immedica Pharma Us Inc
Product Type
Human Prescription Drug
FDA Application #
NDA215904
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-06-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81583-100). Click a package code to view its specific billing and regulatory data.

81583-100-05
5 BOTTLE, PLASTIC in 1 CARTON / 110 mL in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81583-100-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 110 ml in 1 bottle, plastic of Ztalmy, a human prescription drug labeled by Immedica Pharma Us Inc. This suspension is formulated for oral use and contains ganaxolone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Immedica Pharma Us Inc on June 06, 2022. The current certification is valid through December 31, 2026.

How is this Immedica Pharma Us Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81583010001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
81583-100-01
11-Digit CMS (5-4-2)
81583-0100-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.