Augmentin
NDC 54868-0388

View NDC Profile UNII Mappings and RxNorm Concepts.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-0388?
  5. Augmentin 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 discontinued by the firm.

Augmentin is a NDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 54868-0388 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-0388
Proprietary Name:
Augmentin
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
d567412a-e5ed-4c7f-90f0-ea3039786480
FDA Application Number: [6]
NDA050564
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-18-1996
End Marketing Date: [10]
05-31-2011
Listing Expiration Date: [11]
05-31-2011
Exclude Flag: [12]
D

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
20 MM
Imprint(s):
AUGMENTIN;500;125
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-0388?

The NDC code 54868-0388 is assigned by the FDA to the product Augmentin. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 54868-0388-0, 54868-0388-1, 54868-0388-2, 54868-0388-4. 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?

AUGMENTIN 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 AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase−producing organisms susceptible to AUGMENTIN 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 AUGMENTIN. (See Microbiology.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of AUGMENTIN and other antibacterial drugs, AUGMENTIN 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 AUGMENTIN, should be performed together with any indicated surgical procedures.

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:
  • RxCUI: 562251 - amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562251 - amoxicillin 250 MG / clavulanate 125 MG Oral Tablet
  • RxCUI: 562251 - amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet
  • RxCUI: 562508 - amoxicillin 875 MG / clavulanate 125 MG Oral Tablet

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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 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.
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".