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  5. NDC Package Code: 65162-760-84 Azithromycin Monohydrate

NDC Package 65162-760-84 Azithromycin Monohydrate

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

Table of Contents

    1. Package Information
    2. 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:
65162-760-84
Package Description:
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code:
65162-760
Proprietary Name:
Azithromycin Monohydrate
Non-Proprietary Name:
Azithromycin Monohydrate
Substance Name:
Azithromycin Monohydrate
Usage Information:
Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)].
11-Digit NDC Billing Format:
65162076084
NDC to RxNorm Crosswalk:
  • RxCUI: 141963 - azithromycin 200 MG in 5 mL Oral Suspension
  • RxCUI: 141963 - azithromycin 40 MG/ML Oral Suspension
  • RxCUI: 141963 - azithromycin 1200 MG per 30 ML Oral Suspension
  • RxCUI: 141963 - azithromycin 200 MG per 5 ML Oral Suspension
  • RxCUI: 141963 - azithromycin 600 MG per 15 ML Oral Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    Dosage Form:
    Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AZITHROMYCIN MONOHYDRATE 200 mg/5mL
    • Pharmacologic Class(es):
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA205666
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-23-2018
    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.

    Frequently Asked Questions

    What is NDC 65162-760-84?

    The NDC Packaged Code 65162-760-84 is assigned to a package of 1 bottle in 1 carton / 30 ml in 1 bottle of Azithromycin Monohydrate, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is powder, for suspension and is administered via oral form.

    Is NDC 65162-760 included in the NDC Directory?

    Yes, Azithromycin Monohydrate with product code 65162-760 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on July 23, 2018 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 11-digit format for NDC 65162-760-84?

    The 11-digit format is 65162076084. 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
    5-3-265162-760-845-4-265162-0760-84