1. Home
  2. Labeler Index
  3. Xttrium Laboratories, Inc
  4. 0116-4010
  5. NDC Package Code: 0116-4010-41 Amantadine

NDC Package 0116-4010-41 Amantadine

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Amantadine
Non-Proprietary Name:
Amantadine
Substance Name:
Amantadine Hydrochloride
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.
11-Digit NDC Billing Format:
00116401041
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Xttrium Laboratories, Inc
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
AMANTADINE HYDROCHLORIDE 50 mg/5mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA075060
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-05-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0116-4010-16473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0116-4010-41?

The NDC Packaged Code 0116-4010-41 is assigned to a 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. The product's dosage form is solution and is administered via oral form.

Is NDC 0116-4010 included in the NDC Directory?

Yes, Amantadine with product code 0116-4010 is active and included in the NDC Directory. The product was first marketed by Xttrium Laboratories, Inc on November 05, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0116-4010-41?

The 11-digit format is 00116401041. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20116-4010-415-4-200116-4010-41