Amantadine Hydrochloride
NDC Package 73152-075-05

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amantadine Hydrochloride is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Marketed by Athem Llc, this product is identified by NDC 73152-075 and is authorized under FDA application ANDA210215.

Identification & Billing

NDC Package Code
73152-075-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
73152-075
11-Digit Billing Format
73152007505
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Amantadine Hydrochloride
Dosage Form
-
Usage Information
Amantadine Hydrochloride is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.Influenza A ProphylaxisAmantadine Hydrochloride is indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride Tablets do not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, Amantadine Hydrochloride Tablets prophylaxis should be considered for the 2- to 4- week time period required to develop an antibody response.Influenza A TreatmentAmantadine Hydrochloride is also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with Amantadine Hydrochloride will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that Amantadine Hydrochloride Tablets and Capsules are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.The following points should be considered before initiating treatment or prophylaxis with Amantadine Hydrochloride:Amantadine Hydrochloride is not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Amantadine Hydrochloride.Parkinson's Disease / SyndromeAmantadine Hydrochloride is indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. It is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. In the treatment of Parkinson's disease, Amantadine Hydrochloride is less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established.Drug-Induced Extrapyramidal ReactionsAmantadine Hydrochloride is indicated in the treatment of drug-induced extrapyramidal reactions. Although anticholinergic-type side effects have been noted with Amantadine Hydrochloride Tablets when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs.

Regulatory & Marketing

Labeler Name
Athem Llc
FDA Application #
ANDA210215
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-19-2021
Listing Expiration
12-31-2022
Exclude Flag
I
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 (73152-075). Click a package code to view its specific billing and regulatory data.

73152-075-01
100 TABLET 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 73152-075-05 identifies a specific commercial package of 500 tablet in 1 bottle of Amantadine Hydrochloride, labeled by Athem Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Athem Llc on February 19, 2021. The current certification is valid through December 31, 2022.

How is this Athem Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73152007505. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
73152-075-05
11-Digit CMS (5-4-2)
73152-0075-05

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