Eprontia Solution
NDC Package 52652-9001-2

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

Eprontia (topiramate) solution is topiramate is used alone and with other medications to prevent and control seizures (epilepsy). This formulation utilizes a solution delivery system. Marketed by Azurity Pharmaceuticals, Inc., this product is identified by NDC 52652-9001 and is authorized under FDA application NDA214679.

Identification & Billing

NDC Package Code
52652-9001-2
Package Description
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE
Product Code
52652-9001
11-Digit Billing Format
52652900102
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eprontia
Non-Proprietary Name
Topiramate
Substance Name
Topiramate
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)
TOPIRAMATE 25 mg/mL
Pharmacologic Class
Usage Information
Topiramate is used alone and with other medications to prevent and control seizures (epilepsy). It is also used to prevent migraine headaches. Topiramate belongs to a class of drugs known as anticonvulsants.

Regulatory & Marketing

Labeler Name
Azurity Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214679
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-06-2021
Listing Expiration
12-31-2027
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 (52652-9001). Click a package code to view its specific billing and regulatory data.

52652-9001-1
473 mL in 1 BOTTLE
52652-9001-3
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

* 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 52652-9001-2 identifies a specific commercial package of 1 bottle in 1 carton / 240 ml in 1 bottle of Eprontia, a human prescription drug labeled by Azurity Pharmaceuticals, Inc.. This solution is formulated for oral use and contains topiramate 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 December 06, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Topiramate is used alone and with other medications to prevent and control seizures (epilepsy). It is also used to prevent migraine headaches. Topiramate belongs to a class of drugs known as anticonvulsants.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52652900102. 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 (5-4-1)
52652-9001-2
11-Digit CMS (5-4-2)
52652-9001-02

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