Erythromycin Topical Solution 2% Solution
NDC Package 71656-030-60

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

Package Information

Erythromycin Topical Solution 2% solution is erythromycin topical solution, 2% is indicated for the topical treatment of acne vulgaris. This formulation utilizes a solution delivery system. Marketed by Saptalis Pharmaceuticals, Llc Llc, this product is identified by NDC 71656-030 and is authorized under FDA application ANDA062687.

Identification & Billing

NDC Package Code
71656-030-60
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
71656-030
11-Digit Billing Format
71656003060
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Erythromycin Topical Solution 2%
Non-Proprietary Name
Erythromycin Topical Solution 2%
Substance Name
Erythromycin
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
ERYTHROMYCIN 20 mg/mL
Pharmacologic Class
Usage Information
Erythromycin topical solution, 2% is indicated for the topical treatment of acne vulgaris.

Regulatory & Marketing

Labeler Name
Saptalis Pharmaceuticals, Llc Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA062687
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-14-2024
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 71656-030-60 identifies a specific commercial package of 1 bottle in 1 carton / 60 ml in 1 bottle of Erythromycin Topical Solution 2%, a human prescription drug labeled by Saptalis Pharmaceuticals, Llc Llc. This solution is formulated for topical 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 Saptalis Pharmaceuticals, Llc Llc on August 14, 2024. The current certification is valid through December 31, 2026.

How is this Saptalis Pharmaceuticals, Llc Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71656003060. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
71656-030-60
11-Digit CMS (5-4-2)
71656-0030-60

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