Clindamycin Phosphate And Benzoyl Peroxide Gel
NDC Package 51672-1403-4

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

Package Information

Clindamycin Phosphate And Benzoyl Peroxide gel is 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. This formulation utilizes a gel delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1403 and is authorized under FDA application ANDA208683.

Identification & Billing

NDC Package Code
51672-1403-4
Package Description
50 g in 1 BOTTLE, PUMP
Product Code
51672-1403
11-Digit Billing Format
51672140304
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM

Clinical Specifications

Proprietary Name
Clindamycin Phosphate And Benzoyl Peroxide
Non-Proprietary Name
Clindamycin Phosphate And Benzoyl Peroxide
Substance Name
Benzoyl Peroxide; Clindamycin Phosphate
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
Pharmacologic Class
Usage Information
Clindamycin phosphate and benzoyl peroxide gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208683
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-05-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51672-1403-4 identifies a specific commercial package of 50 g in 1 bottle, pump of Clindamycin Phosphate And Benzoyl Peroxide, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This gel is formulated for topical use and contains benzoyl peroxide; 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 Sun Pharmaceutical Industries, Inc. on June 05, 2018. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672140304. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 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 (5-4-1)
51672-1403-4
11-Digit CMS (5-4-2)
51672-1403-04

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