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  5. NDC Package Code: 21695-401-12 Amoxicillin And Clavulanate Potassium

NDC Package 21695-401-12 Amoxicillin And Clavulanate Potassium

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
21695-401-12
Package Description:
125 mL in 1 BOTTLE, DISPENSING
Product Code:
21695-401
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Usage Information:
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/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 for Oral Suspension 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 for Oral Suspension 600 mg/42.9 mg per 5 mL and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension 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:
21695040112
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
125 ML
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:
    Rebel Distributors Corp.
    Sample Package:
    No
    Start Marketing Date:
    08-13-2007
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 CodePackage Description
    21695-401-20200 mL in 1 BOTTLE, DISPENSING

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 21695-401-12?

    The NDC Packaged Code 21695-401-12 is assigned to a package of 125 ml in 1 bottle, dispensing of Amoxicillin And Clavulanate Potassium, labeled by Rebel Distributors Corp.. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 125 billable units per package.

    Is NDC 21695-401 included in the NDC Directory?

    No, Amoxicillin And Clavulanate Potassium with product code 21695-401 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rebel Distributors Corp. on August 13, 2007 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 21695-401-12?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 125.

    What is the 11-digit format for NDC 21695-401-12?

    The 11-digit format is 21695040112. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-221695-401-125-4-221695-0401-12