Memantine Hydrochloride Solution
NDC Package 13925-540-12

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

Package Information

Memantine Hydrochloride (memantine hydrochloride oral) solution is memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. This formulation utilizes a solution delivery system. Marketed by Seton Pharmaceuticals, this product is identified by NDC 13925-540 and is authorized under FDA application ANDA210319.

Identification & Billing

NDC Package Code
13925-540-12
Package Description
360 mL in 1 BOTTLE
Product Code
13925-540
11-Digit Billing Format
13925054012
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
360 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Memantine Hydrochloride
Non-Proprietary Name
Memantine Hydrochloride Oral
Substance Name
Memantine Hydrochloride
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)
MEMANTINE HYDROCHLORIDE 2 mg/mL
Pharmacologic Class
Usage Information
Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

Regulatory & Marketing

Labeler Name
Seton Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA210319
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2020
End Marketing Date
03-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 13925-540-12 identifies a specific commercial package of 360 ml in 1 bottle of Memantine Hydrochloride, a human prescription drug labeled by Seton Pharmaceuticals. This solution is formulated for oral use and contains memantine hydrochloride 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 Seton Pharmaceuticals on August 31, 2020.

How is this Seton Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13925054012. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 360 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)
13925-540-12
11-Digit CMS (5-4-2)
13925-0540-12

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