1. Home
  2. Labeler Index
  3. Aidarex Pharmaceuticals Llc
  4. NDC Product Code: 53217-359 Amoxicillin And Clavulanate Potassium

NDC 53217-359 Amoxicillin And Clavulanate Potassium

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 53217-359?
  4. Amoxicillin And Clavulanate Potassium Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. 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:
53217-359
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aidarex Pharmaceuticals Llc
Labeler Code:
53217
Product Label ID:
9f18d271-7cd8-4a4e-8087-6f11eddf0107
Start Marketing Date: [9]
01-11-2018
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 53217-359-01

Package Description: 75 mL in 1 BOTTLE, DISPENSING

Product Details

What is NDC 53217-359?

The NDC code 53217-359 is assigned by the FDA to the product Amoxicillin And Clavulanate Potassium which is product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 53217-359-01 75 ml in 1 bottle, dispensing . 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?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat 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.Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae(penicillin MICs ≤ 2 mcg/mL), H. influenzae(including β-lactamase-producing strains), or M. catarrhalis(including β-lactamase-producing strains) characterized by the following risk factors: • antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following:- age 2 years or younger- daycare attendance [see CLINICAL PHARMACOLOGY, Microbiology (12.4)].NOTE: Acute otitis media due to S. pneumoniaealone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension, USP is not indicated for the treatment of acute otitis media due to S. pneumoniaewith penicillin MIC ≥ 4 mcg /mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae(penicillin MIC ≤ 2 mcg/mL) and the β-lactamase-producing organisms listed above.

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: 617993 - amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension
  • RxCUI: 617993 - amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension
  • RxCUI: 617993 - amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension
  • RxCUI: 617993 - amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension

* 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".