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  5. NDC Package Code: 42799-118-01 Amantadine Hydrochloride

NDC Package 42799-118-01 Amantadine Hydrochloride

Tablet 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:
42799-118-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
42799-118
Proprietary Name:
Amantadine Hydrochloride
Non-Proprietary Name:
Amantadine Hydrochloride
Substance Name:
Amantadine Hydrochloride
Usage Information:
Amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.Influenza A ProphylaxisAmantadine hydrochloride tablets are 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 tablets are 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 tablets 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 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 tablets:Amantadine hydrochloride tablets are 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 tablets.Parkinson's Disease / SyndromeAmantadine hydrochloride tablets are 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 tablets are 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 tablets are indicated in the treatment of drug-induced extrapyramidalreactions. 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.
11-Digit NDC Billing Format:
42799011801
NDC to RxNorm Crosswalk:
  • RxCUI: 849395 - amantadine HCl 100 MG Oral Tablet
  • RxCUI: 849395 - amantadine hydrochloride 100 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Edenbridge Pharmaceuticals Llc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMANTADINE HYDROCHLORIDE 100 mg/1
    • Pharmacologic Class(es):
  • Influenza A M2 Protein Inhibitor - [EPC] (Established Pharmacologic Class)
  • M2 Protein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA212407
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-15-2022
    Listing Expiration Date:
    12-31-2024
    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
    42799-118-02500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42799-118-01?

    The NDC Packaged Code 42799-118-01 is assigned to a package of 100 tablet in 1 bottle of Amantadine Hydrochloride, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 42799-118 included in the NDC Directory?

    Yes, Amantadine Hydrochloride with product code 42799-118 is active and included in the NDC Directory. The product was first marketed by Edenbridge Pharmaceuticals Llc. on September 15, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 42799-118-01?

    The 11-digit format is 42799011801. 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 5-3-2 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
    5-3-242799-118-015-4-242799-0118-01