Towerx Effervescent Potassium
NDC 50201-2400

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.

Towerx Effervescent Potassium is a UNAPPROVED DRUG OTHER-approved product labeled by Tower Laboratories Ltd. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a orange product. This product entry covers the primary NDC 50201-2400 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50201-2400
Proprietary Name:
Towerx Effervescent Potassium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
50201
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]
01-06-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
ROUND (C48348)
Size(s):
25 MM
Imprint(s):
T
Score:
2
Flavor(s):

Code Structure Chart

Product Details

What is NDC 50201-2400?

The NDC code 50201-2400 is assigned by the FDA to the product Towerx Effervescent Potassium. This pharmaceutical product is labeled by Tower Laboratories Ltd and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 50201-2400-2, 50201-2400-4, 50201-2400-6. 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?

INDICATIONS AN USAGE:1. For therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in digitalis intoxication and in patients with hypokalemic familial    periodic paralysis.2. For prevention of potassium depletion when the dietary intake of potassium is inadequate in the following conditions; patients receiving digitalis and    diuretics for congestive heart failure; hepatic cirrhosis with ascites; states of aldosterone excess with normal renal function; potassium-losing    nephropathy, and certain diarrheal states.3. The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a    normal dietary pattern.  Serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with    potassium-containing foods may be adequate to control milder cases.  In more severe cases supplementation with potassium salts may be    indicated.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 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:

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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".