Amantadine Hydrochloride
NDC Package 54868-3216-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 syrup (amantadine hydrochloride oral solution, USP) is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-3216 and is authorized under FDA application ANDA075060.

Identification & Billing

NDC Package Code
54868-3216-0
Package Description
473 mL in 1 BOTTLE
Product Code
54868-3216
11-Digit Billing Format
54868321600
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
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 Hydrochloride
Dosage Form
-
Usage Information
Amantadine hydrochloride syrup (amantadine hydrochloride oral solution, USP) 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 when early vaccination is not feasible or when the vaccine is contraindicated or not available. In the prophylaxis of influenza, early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee is the method of choice. Because amantadine does 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 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 will avoid the development of influenza A virus pneumonitis or other complications in high risk patients.There is no clinical evidence indicating that amantadine is effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains.Parkinson's Disease/SyndromeAmantadine 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 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 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
Physicians Total Care, Inc.
FDA Application #
ANDA075060
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-23-2005
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-3216-0 identifies a specific commercial package of 473 ml in 1 bottle of Amantadine Hydrochloride, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 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 Physicians Total Care, Inc. on February 23, 2005. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868321600. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (5-4-1)
54868-3216-0
11-Digit CMS (5-4-2)
54868-3216-00

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