NDC 54868-0286-0 HUMAN PRESCRIPTION DRUG

Drug Status:  Deprecated

Proprietary Name: Amoxicillin And Clavulanate Potassium

Drug Overview

The NDC Code 54868-0286-0 is assigned to “Amoxicillin And Clavulanate Potassium ” (also known as: “Amoxicillin And Clavulanate Potassium”), a human prescription drug labeled by “Physicians Total Care, Inc.”. The product's dosage form is tablet, chewable, and is administered via oral form.

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Drug Information
NDC Package Code	54868-0286-0
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	54868-0286
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	54868-0286-00
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Amoxicillin And Clavulanate Potassium
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Amoxicillin And Clavulanate Potassium
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN PRESCRIPTION DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Physicians Total Care, Inc.
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Deprecated
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	Powder for Oral Suspension:Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension 200 mg/5 mL contains 0.14 mEq potassium. Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension 400 mg/5 mL contains 0.29 mEq of potassium. Inactive Ingredients: Aspartame, colloidal silicon dioxide, flavor strawberry, flavor strawberry guarana, monosodium citrate, silicon dioxide, sodium citrate (as dihydrate), xanthan gum. Chewable Tablets:Each 200 mg/28.5 mg chewable tablet contains 0.15 mEq potassium. Each 400 mg chewable tablet contains 0.30 mEq of potassium. Inactive Ingredients: Aspartame, FD&C red No. 40 aluminum lake, glycine, povidone, magnesium stearate, mannitol, mint cream flavor, orange cream flavor, silicon dioxide, sodium starch glycolate, tropical blend flavor. See PRECAUTIONS–Information for the Patient.
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	Amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be performed together with any indicated surgical procedures.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	TABLET, CHEWABLE
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	ORAL
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	BETA LACTAMASE INHIBITOR [EPC],BETA LACTAMASE INHIBITORS [MOA]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	AMOXICILLIN - 400 mg/1 CLAVULANATE POTASSIUM - 57 mg/1
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	54868-0286-0
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	20 TABLET, CHEWABLE IN 1 BOTTLE (54868-0286-0)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N/S (NOT SPECIFIED)
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N/S (NOT SPECIFIED)
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	N/S (NOT SPECIFIED)
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package 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. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	54868-0286
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	ANDA065161
	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.
Marketing Category Name	ANDA
	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.
Listing Record Certified Through	20171231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20070813
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	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.
Product NDC Exclude Flag	E
	This 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.

Tracking Information
Last Update Date	2018-07-24
	The date that a record was last updated or changed.