NDC 50383-807 Amantadine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50383-807
Proprietary Name:
Amantadine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Akorn
Labeler Code:
50383
Start Marketing Date: [9]
10-28-1994
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Flavor(s):
RASPBERRY (C73413 - ARTIFICIAL)

Product Packages

NDC Code 50383-807-16

Package Description: 473 mL in 1 BOTTLE

Price per Unit: $0.02151 per ML

Product Details

What is NDC 50383-807?

The NDC code 50383-807 is assigned by the FDA to the product Amantadine Hydrochloride which is product labeled by Akorn. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50383-807-16 473 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Amantadine Hydrochloride?

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 druginduced extrapyramidal reactions.

Which are Amantadine Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Amantadine Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Amantadine Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Amantadine


Amantadine is used to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) and other similar conditions. It is also used to control movement problems that are a side effect of certain medications used to treat Parkinson's disease. Amantadine extended-release capsules (Gocovri) are used along with the combination of levodopa and carbidopa (Rytary, Sinemet) to treat ''off'' episodes (times of difficulty moving, walking, and speaking that may happen when other medications wear off) in people with Parkinson's disease. It also is used to prevent symptoms of influenza A virus infection and for treatment of respiratory infections caused by influenza A virus. Amantadine is in a class of medications called adamantanes. It is thought to work to control movement problems by increasing the amount of dopamine in certain parts of the body. It works against influenza A virus by stopping the spread of the virus in the body.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".