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  5. NDC Package Code: 65427-416-01 Azithromycin Dihydrate

NDC Package 65427-416-01 Azithromycin Dihydrate

Tablet, Film Coated - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
65427-416-01
Package Description:
1 BAG in 1 DRUM / 672812 TABLET, FILM COATED in 1 BAG
Product Code:
65427-416
Non-Proprietary Name:
Azithromycin Dihydrate
Substance Name:
Azithromycin Dihydrate
11-Digit NDC Billing Format:
65427041601
Product Type:
Drug For Further Processing
Labeler Name:
Pfizer Pharmaceuticals Llc
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.
Active Ingredient(s):
  • AZITHROMYCIN DIHYDRATE 500 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    EXPORT ONLY - A product that is only exported and not marketed in the United States.
    Start Marketing Date:
    07-11-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 65427-416-01?

    The NDC Packaged Code 65427-416-01 is assigned to an UNFINISHED drug package of 1 bag in 1 drum / 672812 tablet, film coated in 1 bag of Azithromycin Dihydrate, drug for further processing labeled by Pfizer Pharmaceuticals Llc. The product's dosage form is tablet, film coated and is administered via form.

    Is NDC 65427-416 included in the NDC Directory?

    Yes, Azithromycin Dihydrate is an UNFINISHED PRODUCT with code 65427-416 that is active and included in the NDC Directory. The product was first marketed by Pfizer Pharmaceuticals Llc on July 11, 2022 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 65427-416-01?

    The 11-digit format is 65427041601. 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
    5-3-265427-416-015-4-265427-0416-01