NDC 68996-102 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:
68996-102
Proprietary Name:
Amantadine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Newgen Pharmaceuticals Llc
Labeler Code:
68996
Start Marketing Date: [9]
02-28-2017
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
A;100
Score:
1

Product Packages

NDC Code 68996-102-01

Package Description: 10 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

NDC Code 68996-102-30

Package Description: 30 CAPSULE in 1 BOTTLE, PLASTIC

NDC Code 68996-102-50

Package Description: 500 CAPSULE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 68996-102?

The NDC code 68996-102 is assigned by the FDA to the product Amantadine Hydrochloride which is product labeled by Newgen Pharmaceuticals Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 68996-102-01 10 blister pack in 1 carton / 10 capsule in 1 blister pack, 68996-102-30 30 capsule in 1 bottle, plastic , 68996-102-50 500 capsule in 1 bottle, plastic . 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 capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced 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:

* Please review the disclaimer below.

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".