Clindacin Etz Swab
NDC Package 43538-172-60

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

Clindacin Etz (clindamycin phosphate) swabs is a medication used to treat acne. This formulation utilizes a swab delivery system. Marketed by Eurofarma, Inc., this product is identified by NDC 43538-172 and is authorized under FDA application ANDA065049.

Identification & Billing

NDC Package Code
43538-172-60
Package Description
60 PACKET in 1 CARTON / 1 SWAB in 1 PACKET
Product Code
43538-172
11-Digit Billing Format
43538017260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindacin Etz
Non-Proprietary Name
Clindamycin Phosphate
Substance Name
Clindamycin Phosphate
Dosage Form
Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.
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)
CLINDAMYCIN PHOSPHATE 10 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat acne. It helps to decrease the number of acne lesions. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Eurofarma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065049
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2013
Listing Expiration
12-31-2027
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 (43538-172). Click a package code to view its specific billing and regulatory data.

43538-172-99
12 PACKET in 1 CARTON / 1 SWAB in 1 PACKET

* 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 43538-172-60 identifies a specific commercial package of 60 packet in 1 carton / 1 swab in 1 packet of Clindacin Etz, a human prescription drug labeled by Eurofarma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This swab is formulated for topical use and contains clindamycin phosphate 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 Eurofarma, Inc. on June 15, 2013. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat acne. It helps to decrease the number of acne lesions. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43538017260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
43538-172-60
11-Digit CMS (5-4-2)
43538-0172-60

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