NDC Package 58118-0019-7 Amoxicillin And Clavulanate Potassium

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Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

58118-0019-7

Package Description:

75 mL in 1 BOTTLE

Product Code:

58118-0019

Proprietary Name:

Amoxicillin And Clavulanate Potassium

Usage Information:

Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL 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 daycare attendance [See CLINICAL PHARMACOLOGY, Microbiology.] NOTE: Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL and other antibacterial drugs, Amoxicillin and Clavulanate Potassium 600 mg/42.9 mg per 5 mL 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.

11-Digit NDC Billing Format:

58118001907

NDC to RxNorm Crosswalk:

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

Labeler Name:

Clinical Solutions Wholesale

Sample Package:

FDA Application Number:

ANDA050755

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

06-22-2001

End Marketing Date:

06-21-2017

Listing Expiration Date:

06-21-2017

Exclude Flag:

Code Structure:

58118 - Clinical Solutions Wholesale
- 58118-0019 - Amoxicillin And Clavulanate Potassium
  - 58118-0019-7 - 75 mL in 1 BOTTLE

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
58118-0019-2	200 mL in 1 BOTTLE
58118-0019-5	125 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58118-0019-7?

The NDC Packaged Code 58118-0019-7 is assigned to a package of 75 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, labeled by Clinical Solutions Wholesale. The product's dosage form is and is administered via form.

Is NDC 58118-0019 included in the NDC Directory?

The product was first marketed by Clinical Solutions Wholesale on June 22, 2001 and its listing in the NDC Directory is set to expire on June 21, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58118-0019-7?

The 11-digit format is 58118001907. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	58118-0019-7	5-4-2	58118-0019-07

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