Azithromycin Tablet, Film Coated
NDC Package 70518-3508-2

11-digit billing NDC: 70518350802
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Azithromycin tablets are indicated in adult patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis,or Streptococcus pneumoniae. This formulation utilizes a tablet, film coated delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-3508 and is authorized under FDA application ANDA207398.

Identification & Billing

NDC Package Code
70518-3508-2
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
70518-3508
11-Digit Billing Format
70518350802
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azithromycin
Non-Proprietary Name
Azithromycin
Substance Name
Azithromycin Dihydrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AZITHROMYCIN DIHYDRATE 500 mg/1
Pharmacologic Class
Usage Information
Azithromycin tablets are indicated in adult patients for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: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 pneumoniaein patients appropriate for oral therapy. Pharyngitis/tonsillitis caused by Streptococcus pyogenesas 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 trachomatisor 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.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207398
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-05-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-3508). Click a package code to view its specific billing and regulatory data.

70518-3508-0
2 POUCH in 1 BOX / 1 TABLET, FILM COATED in 1 POUCH (70518-3508-1)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-3508-2 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Azithromycin, a human prescription drug labeled by Remedyrepack Inc.. This tablet, film coated is formulated for oral use and contains azithromycin dihydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Remedyrepack Inc. on September 05, 2022. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518350802. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
70518-3508-2
11-Digit CMS (5-4-2)
70518-3508-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.