Amantadine Solution
NDC Package 0116-4010-41

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

Amantadine solution is amantadine is used to prevent or treat a certain type of flu (influenza A). This formulation utilizes a solution delivery system. Marketed by Xttrium Laboratories, Inc, this product is identified by NDC 0116-4010 and is authorized under FDA application ANDA075060.

Identification & Billing

NDC Package Code
0116-4010-41
Package Description
100 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)
Product Code
0116-4010
11-Digit Billing Format
00116401041
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 849385 - amantadine HCl 50 MG in 5 mL Oral Solution
  • RxCUI: 849385 - amantadine hydrochloride 10 MG/ML Oral Solution
  • RxCUI: 849385 - amantadine hydrochloride 100 MG per 10 ML Oral Solution
  • RxCUI: 849385 - amantadine hydrochloride 50 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Amantadine
Non-Proprietary Name
Amantadine
Substance Name
Amantadine 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)
AMANTADINE HYDROCHLORIDE 50 mg/5mL
Pharmacologic Class
Usage Information
Amantadine is used to prevent or treat a certain type of flu (influenza A). If you have been infected with the flu, this medication may help make your symptoms less severe and shorten the time it will take you to get better. Taking amantadine if you have been or will be exposed to the flu may help to prevent you from getting the flu. This medication is an antiviral that is believed to work by stopping growth of the flu virus. This medication is not a vaccine. To increase the chance that you will not get the flu, it is important to get a flu shot once a year at the beginning of every flu season, if possible. Based on the recommendation from the Centers for Disease Control (CDC) in the US, amantadine should not be used to treat or prevent influenza A because the current influenza A virus in the United States and Canada is resistant to this medication. For more details, talk to your doctor or pharmacist. Amantadine is also used to treat Parkinson's disease, as well as side effects caused by drugs (e.g., drug-induced extrapyramidal symptoms), chemicals, other medical conditions. In these cases, this medication may help to improve your range of motion and ability to exercise. For the treatment of these conditions, amantadine is believed to work by restoring the balance of natural chemicals (neurotransmitters) in the brain.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA075060
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-05-2024
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 (0116-4010). Click a package code to view its specific billing and regulatory data.

0116-4010-16
473 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 0116-4010-41 identifies a specific commercial package of 100 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose (0116-4010-10) of Amantadine, a human prescription drug labeled by Xttrium Laboratories, Inc. This solution is formulated for oral use and contains amantadine 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 Xttrium Laboratories, Inc on November 05, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Amantadine is used to prevent or treat a certain type of flu (influenza A). If you have been infected with the flu, this medication may help make your symptoms less severe and shorten the time it will take you to get better. Taking amantadine if you have been or will be exposed to the flu may help to prevent you from getting the flu. This medication is an antiviral that is believed to work by stopping growth of the flu virus. This medication is not a vaccine. To increase the chance that you will not get the flu, it is important to get a flu shot once a year at the beginning of every flu season, if possible. Based on the recommendation from the Centers for Disease Control (CDC) in the US, amantadine should not be used to treat or prevent influenza A because the current influenza A virus in the United States and Canada is resistant to this medication. For more details, talk to your doctor or pharmacist. Amantadine is also used to treat Parkinson's disease, as well as side effects caused by drugs (e.g., drug-induced extrapyramidal symptoms), chemicals, other medical conditions. In these cases, this medication may help to improve your range of motion and ability to exercise. For the treatment of these conditions, amantadine is believed to work by restoring the balance of natural chemicals (neurotransmitters) in the brain.

How is this Xttrium Laboratories, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116401041. 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 (4-4-2)
0116-4010-41
11-Digit CMS (5-4-2)
00116-4010-41

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