Amantadine Capsule
NDC Package 60687-422-01

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

Package Information

Amantadine capsules is amantadine is used to prevent or treat a certain type of flu (influenza A). This formulation utilizes a capsule delivery system. Marketed by American Health Packaging, this product is identified by NDC 60687-422 and is authorized under FDA application ANDA208966.

Identification & Billing

NDC Package Code
60687-422-01
Package Description
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 CAPSULE in 1 BLISTER PACK (60687-422-11)
Product Code
60687-422
11-Digit Billing Format
60687042201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Amantadine
Non-Proprietary Name
Amantadine
Substance Name
Amantadine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AMANTADINE HYDROCHLORIDE 100 mg/1
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
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA208966
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60687-422-01 identifies a specific commercial package of 100 blister pack in 1 box, unit-dose / 1 capsule in 1 blister pack (60687-422-11) of Amantadine, a human prescription drug labeled by American Health Packaging. This capsule 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 American Health Packaging on May 01, 2019. 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 American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60687042201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
60687-422-01
11-Digit CMS (5-4-2)
60687-0422-01

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