Erythromycin Ethylsuccinate Granule, For Suspension
NDC Package 62559-440-01

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

Package Information

Erythromycin Ethylsuccinate granules is erythromycin is used to treat a wide variety of bacterial infections. This formulation utilizes a granule, for suspension delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 62559-440 and is authorized under FDA application ANDA062055.

Identification & Billing

NDC Package Code
62559-440-01
Package Description
100 mL in 1 BOTTLE
Product Code
62559-440
11-Digit Billing Format
62559044001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
RxNorm Crosswalk
  • RxCUI: 686400 - erythromycin ethylsuccinate 200 MG in 5 mL Oral Suspension
  • RxCUI: 686400 - erythromycin ethylsuccinate 40 MG/ML Oral Suspension
  • RxCUI: 686400 - EES 40 MG/ML Oral Suspension
  • RxCUI: 686400 - erythromycin ethylsuccinate 200 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Erythromycin Ethylsuccinate
Non-Proprietary Name
Erythromycin Ethylsuccinate
Substance Name
Erythromycin Ethylsuccinate
Dosage Form
Granule, For Suspension - A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ERYTHROMYCIN ETHYLSUCCINATE 200 mg/5mL
Pharmacologic Class
Usage Information
Erythromycin is used to treat a wide variety of bacterial infections. It may also be used to prevent certain bacterial infections. Erythromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria. This antibiotic treats or prevents only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA062055
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-27-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62559-440). Click a package code to view its specific billing and regulatory data.

62559-440-02
200 mL in 1 BOTTLE

* 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 62559-440-01 identifies a specific commercial package of 100 ml in 1 bottle of Erythromycin Ethylsuccinate, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This granule, for suspension is formulated for oral use and contains erythromycin ethylsuccinate 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 Ani Pharmaceuticals, Inc. on September 27, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Erythromycin is used to treat a wide variety of bacterial infections. It may also be used to prevent certain bacterial infections. Erythromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria. This antibiotic treats or prevents only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Ani Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62559044001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 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)
62559-440-01
11-Digit CMS (5-4-2)
62559-0440-01

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