Erythromycin Ointment
NDC Package 67296-2128-3

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

Package Information

Erythromycin ointment is a medication used to treat certain eye infections (such as conjunctivitis). This formulation utilizes a ointment delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2128 and is authorized under FDA application ANDA064030.

Identification & Billing

NDC Package Code
67296-2128-3
Package Description
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
Product Code
67296-2128
11-Digit Billing Format
67296212803

Clinical Specifications

Proprietary Name
Erythromycin
Non-Proprietary Name
Erythromycin
Substance Name
Erythromycin
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
ERYTHROMYCIN 5 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat certain eye infections (such as conjunctivitis). It is also used to prevent certain eye infections in newborns. It belongs to a class of drugs known as macrolide antibiotics. Erythromycin works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA064030
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-18-2023
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 67296-2128-3 identifies a specific commercial package of 1 tube in 1 carton / 3.5 g in 1 tube of Erythromycin, a human prescription drug labeled by Redpharm Drug. This ointment is formulated for ophthalmic use and contains erythromycin 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 Redpharm Drug on October 18, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain eye infections (such as conjunctivitis). It is also used to prevent certain eye infections in newborns. It belongs to a class of drugs known as macrolide antibiotics. Erythromycin works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296212803. 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)
67296-2128-3
11-Digit CMS (5-4-2)
67296-2128-03

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