Azithromycin Injection, Powder, Lyophilized, For Solution
NDC Package 70436-019-82

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

Package Information

Azithromycin (azithromycin dihydrate) injection is azithromycin is used to treat a wide variety of bacterial infections. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Slate Run Pharmaceuticals, this product is identified by NDC 70436-019 and is authorized under FDA application ANDA203412.

Identification & Billing

NDC Package Code
70436-019-82
Package Description
10 VIAL in 1 BOX / 5 mL in 1 VIAL
Product Code
70436-019
11-Digit Billing Format
70436001982
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Azithromycin
Non-Proprietary Name
Azithromycin Dihydrate
Substance Name
Azithromycin Dihydrate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AZITHROMYCIN DIHYDRATE 500 mg/5mL
Pharmacologic Class
Usage Information
Azithromycin is used to treat a wide variety of bacterial infections. It is a macrolide-type antibiotic. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Slate Run Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
ANDA203412
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-19-2018
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0456
Source: PDAC
INJECTION, AZITHROMYCIN, 500 MG
HCPCS Dosage 500 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 70436-019-82 identifies a specific commercial package of 10 vial in 1 box / 5 ml in 1 vial of Azithromycin, a human prescription drug labeled by Slate Run Pharmaceuticals. This injection, powder, lyophilized, for solution is formulated for intravenous 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 Slate Run Pharmaceuticals on December 19, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Azithromycin is used to treat a wide variety of bacterial infections. It is a macrolide-type antibiotic. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Slate Run Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436001982. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
70436-019-82
11-Digit CMS (5-4-2)
70436-0019-82

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