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  5. NDC Package Code: 53002-7221-2 Azithromycin Dihydrate

NDC Package 53002-7221-2 Azithromycin Dihydrate

Tablet, Film Coated 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:
53002-7221-2
Package Description:
2 TABLET, FILM COATED in 1 BOTTLE
Product Code:
53002-7221
Proprietary Name:
Azithromycin Dihydrate
Non-Proprietary Name:
Azithromycin Dihydrate
Substance Name:
Azithromycin Dihydrate
Usage Information:
Azithromycin 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:
53002722102
NDC to RxNorm Crosswalk:
  • RxCUI: 248656 - azithromycin 500 MG Oral Tablet
  • RxCUI: 248656 - azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AZITHROMYCIN DIHYDRATE 500 mg/1
    • Pharmacologic Class(es):
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA208249
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-01-2019
    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
    53002-7221-55 TABLET, FILM COATED in 1 BOTTLE
    53002-7221-66 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53002-7221-2?

    The NDC Packaged Code 53002-7221-2 is assigned to a package of 2 tablet, film coated in 1 bottle of Azithromycin Dihydrate, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 53002-7221 included in the NDC Directory?

    Yes, Azithromycin Dihydrate with product code 53002-7221 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on July 01, 2019 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 53002-7221-2?

    The 11-digit format is 53002722102. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-153002-7221-25-4-253002-7221-02