Nymalize Solution
NDC Package 24338-260-08

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

Nymalize (nimodipine) solution is nimodipine is used to decrease problems due to a certain type of bleeding in the brain (subarachnoid hemorrhage-SAH). This formulation utilizes a solution delivery system. Marketed by Azurity Pharmaceuticals, Inc., this product is identified by NDC 24338-260 and is authorized under FDA application NDA203340.

Identification & Billing

NDC Package Code
24338-260-08
Package Description
237 mL in 1 BOTTLE
Product Code
24338-260
11-Digit Billing Format
24338026008
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nymalize
Non-Proprietary Name
Nimodipine
Substance Name
Nimodipine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NIMODIPINE 60 mg/10mL
Pharmacologic Class
Usage Information
Nimodipine is used to decrease problems due to a certain type of bleeding in the brain (subarachnoid hemorrhage-SAH). Nimodipine is called a calcium channel blocker. The body naturally responds to bleeding by narrowing the blood vessel to slow blood flow. However, when the bleeding is in the brain, stopping blood flow causes more brain damage. Nimodipine is thought to work by relaxing narrowed blood vessels in the brain near the area of bleeding so blood can flow more easily. This effect reduces brain damage.

Regulatory & Marketing

Labeler Name
Azurity Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203340
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-04-2020
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 (24338-260). Click a package code to view its specific billing and regulatory data.

24338-260-12
12 PACKAGE in 1 CARTON / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-260-10) / 10 mL in 1 SYRINGE, 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 24338-260-08 identifies a specific commercial package of 237 ml in 1 bottle of Nymalize, a human prescription drug labeled by Azurity Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 237 billable units per package. This solution is formulated for oral use and contains nimodipine 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 Azurity Pharmaceuticals, Inc. on May 04, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Nimodipine is used to decrease problems due to a certain type of bleeding in the brain (subarachnoid hemorrhage-SAH). Nimodipine is called a calcium channel blocker. The body naturally responds to bleeding by narrowing the blood vessel to slow blood flow. However, when the bleeding is in the brain, stopping blood flow causes more brain damage. Nimodipine is thought to work by relaxing narrowed blood vessels in the brain near the area of bleeding so blood can flow more easily. This effect reduces brain damage.

How is this Azurity Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24338026008. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 total billable units per package. 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)
24338-260-08
11-Digit CMS (5-4-2)
24338-0260-08

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