Atuss Ds Tannate Suspension
NDC 59702-800

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

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

Atuss Ds Tannate Suspension is a UNAPPROVED DRUG OTHER-approved product labeled by Atley Pharmaceuticals, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a purple product. This product entry covers the primary NDC 59702-800 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
59702-800
Proprietary Name:
Atuss Ds Tannate Suspension
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
59702
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
11-21-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
PURPLE (C48327 - GRAPE)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 59702-800?

The NDC code 59702-800 is assigned by the FDA to the product Atuss Ds Tannate Suspension. This pharmaceutical product is labeled by Atley Pharmaceuticals, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 59702-800-15, 59702-800-16. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Atuss® DS Tannate Suspension is indicated for temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis and asthma when these conditions are complicated by tenacious mucus and/or mucous plugs and congestion. Atuss® DS Tannate Suspension is effective in a productive as well as a nonproductive cough, but is of particular value in a dry nonproductive cough which tends to injure the mucous membrane of the air passages.

Which are the associated UNII Codes?

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

What is the NDC to RxNorm Crosswalk for this product?

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:
  • RxCUI: 668752 - chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 6 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Extended Release Suspension
  • RxCUI: 668752 - chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / pseudoephedrine HCl 30 MG per 5 ML Extended Release Suspension
  • RxCUI: 668995 - chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 6 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Extended Release Suspension [Atuss DS]
  • RxCUI: 668995 - Atuss DS (chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG / pseudoephedrine HCl 30 MG) per 5 ML Extended Release Suspension

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".