1. Home
  2. Labeler Index
  3. Hikma Pharmaceuticals Usa Inc.
  4. 0143-9853
  5. NDC Package Code: 0143-9853-24 Amoxicillin And Clavulanate Potassium

NDC Package 0143-9853-24 Amoxicillin And Clavulanate Potassium

Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

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

Package Information

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:
0143-9853-24
Package Description:
200 mL in 1 BOTTLE
Product Code:
0143-9853
Proprietary Name:
Amoxicillin And Clavulanate Potassium
Non-Proprietary Name:
Amoxicillin And Clavulanate Potassium
Substance Name:
Amoxicillin; Clavulanate Potassium
Usage Information:
Amoxicillin and clavulanate potassium for oral suspension, 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 for oral suspension, 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 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:
00143985324
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
200 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMOXICILLIN 600 mg/5mL
  • CLAVULANATE POTASSIUM 42.9 mg/5mL
    • Pharmacologic Class(es):
  • Penicillin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Penicillins - [CS]
  • beta Lactamase Inhibitor - [EPC] (Established Pharmacologic Class)
  • beta Lactamase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA065373
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-03-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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
    0143-9853-16125 mL in 1 BOTTLE
    0143-9853-7575 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0143-9853-24?

    The NDC Packaged Code 0143-9853-24 is assigned to a package of 200 ml in 1 bottle of Amoxicillin And Clavulanate Potassium, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is suspension and is administered via oral form.

    Is NDC 0143-9853 included in the NDC Directory?

    Yes, Amoxicillin And Clavulanate Potassium with product code 0143-9853 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on August 03, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0143-9853-24?

    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 200.

    What is the 11-digit format for NDC 0143-9853-24?

    The 11-digit format is 00143985324. 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 4-4-2 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
    4-4-20143-9853-245-4-200143-9853-24