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  5. NDC Package Code: 70518-3453-1 Azithromycin Monohydrate

NDC Package 70518-3453-1 Azithromycin Monohydrate

Tablet 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:
70518-3453-1
Package Description:
1 BOX in 1 POUCH / 30 TABLET in 1 BOX (70518-3453-0)
Product Code:
70518-3453
Proprietary Name:
Azithromycin Monohydrate
Non-Proprietary Name:
Azithromycin Monohydrate
Substance Name:
Azithromycin Monohydrate
Usage Information:
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae . Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis or Streptococcus pneumoniae . Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy. Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae . Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae . Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
11-Digit NDC Billing Format:
70518345301
Product Type:
Human Prescription Drug
Labeler Name:
Remedyrepack Inc.
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AZITHROMYCIN MONOHYDRATE 500 mg/1
    • Pharmacologic Class(es):
  • Macrolide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Macrolides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA065399
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-18-2022
    End Marketing Date:
    07-31-2024
    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 70518-3453-1?

    The NDC Packaged Code 70518-3453-1 is assigned to a package of 1 box in 1 pouch / 30 tablet in 1 box (70518-3453-0) of Azithromycin Monohydrate, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 70518-3453 included in the NDC Directory?

    Yes, Azithromycin Monohydrate with product code 70518-3453 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on July 18, 2022.

    What is the 11-digit format for NDC 70518-3453-1?

    The 11-digit format is 70518345301. 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
    5-4-170518-3453-15-4-270518-3453-01