Azithromycin Dihydrate Tablet
NDC Package 80425-0431-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Azithromycin Dihydrate tablets is acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis,or Streptococcus pneumoniae. This formulation utilizes a tablet delivery system. Marketed by Advanced Rx Of Tennessee, Llc, this product is identified by NDC 80425-0431 and is authorized under FDA application ANDA065398.

Identification & Billing

NDC Package Code
80425-0431-1
Package Description
6 TABLET in 1 BLISTER PACK
Product Code
80425-0431
11-Digit Billing Format
80425043101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azithromycin Dihydrate
Non-Proprietary Name
Azithromycin Dihydrate
Substance Name
Azithromycin Dihydrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AZITHROMYCIN DIHYDRATE 250 mg/1
Pharmacologic Class
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 catarrhalisor 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
Advanced Rx Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065398
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2024
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80425-0431-1 identifies a specific commercial package of 6 tablet in 1 blister pack of Azithromycin Dihydrate, a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. This tablet 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 Advanced Rx Of Tennessee, Llc on August 27, 2024. The current certification is valid through December 31, 2026.

How is this Advanced Rx Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425043101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 total billable units per package. 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)
80425-0431-1
11-Digit CMS (5-4-2)
80425-0431-01

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