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  4. NDC Product Code: 42254-282 Amoxicillin And Clavulanate Potassium

NDC 42254-282 Amoxicillin And Clavulanate Potassium

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 42254-282?
  5. Amoxicillin And Clavulanate Potassium Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
42254-282
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rebel Distributors Corp
Labeler Code:
42254
Product Label ID:
f0c660da-4198-4d04-87e9-5d6a7b6f75cf
FDA Application Number: [6]
NDA050575
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-22-1990
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Flavor(s):
ORANGE (C73406)

Code Structure Chart

Product Details

What is NDC 42254-282?

The NDC code 42254-282 is assigned by the FDA to the product Amoxicillin And Clavulanate Potassium which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 42254-282-00 100 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 Amoxicillin And Clavulanate Potassium?

Amoxicillin and Clavulanate Potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:Lower Respiratory Tract Infections − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis.Otitis Media − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis. Sinusitis − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections − caused by β-lactamase−producing strains of S. aureus, E. coli, and Klebsiella spp. Urinary Tract Infections − caused by β-lactamase−producing strains of E. coli, Klebsiella spp. and Enterobacter spp. While Amoxicillin and Clavulanate Potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Amoxicillin and Clavulanate Potassium due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase−producing organisms susceptible to Amoxicillin and Clavulanate Potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and Amoxicillin and Clavulanate Potassium. (See Microbiology.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Bacteriological studies, to determine the causative organisms and their susceptibility to Amoxicillin and Clavulanate Potassium, should be performed together with any indicated surgical procedures.

Which are Amoxicillin And Clavulanate Potassium UNII Codes?

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

Which are Amoxicillin And Clavulanate Potassium 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 Amoxicillin And Clavulanate Potassium?

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: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension
  • RxCUI: 617430 - amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension
  • RxCUI: 617430 - amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension
  • RxCUI: 617430 - amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension

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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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] 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.

[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".