NDC 33261-773 Amantadine Hydrochloride

Product Information

Product Code33261-773
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Amantadine Hydrochloride
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Aidarex Pharmaceuticals Llc
Labeler Code33261
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-18-1987
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)RED (C48326)
ShapeCAPSULE (C48336)
Size(s)18 MM
Imprint(s)GG634
Score1

Product Packages

NDC 33261-773-10

Package Description: 10 CAPSULE in 1 BOTTLE, PLASTIC

NDC 33261-773-30

Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

NDC 33261-773-60

Package Description: 60 CAPSULE in 1 BOTTLE, PLASTIC

NDC 33261-773-90

Package Description: 90 CAPSULE in 1 BOTTLE, PLASTIC

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

Product Details

Amantadine Hydrochloride is product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is and is administered via form.


What are Amantadine Hydrochloride Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • AMANTADINE HYDROCHLORIDE (UNII: M6Q1EO9TD0)
  • AMANTADINE (UNII: BF4C9Z1J53) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? 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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)


* Please review the disclaimer below.

Patient Education

Amantadine

Amantadine is pronounced as (a man' ta deen)

Why is amantadine medication prescribed?
Amantadine is used to treat Parkinson's disease and conditions similar to those of Parkinson's disease. It also is used to prevent and treat respiratory infections caused...
[Read More]

* Please review the disclaimer below.

Amantadine Hydrochloride Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



* Please review the disclaimer below.