Clindamycin Phosphate And Benzoyl Peroxide Kit
NDC Package 51672-1381-2

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

Clindamycin Phosphate And Benzoyl Peroxide (clindamycin and benzoyl peroxide gel) kits is clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris. This formulation utilizes a kit delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1381 and is authorized under FDA application ANDA208776.

Identification & Billing

NDC Package Code
51672-1381-2
Package Description
1 KIT in 1 CARTON * 5 g in 1 BOTTLE, PLASTIC (51672-1382-1) * 20 g in 1 JAR
Product Code
51672-1381
11-Digit Billing Format
51672138102
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Phosphate And Benzoyl Peroxide
Non-Proprietary Name
Clindamycin And Benzoyl Peroxide Gel
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208776
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-21-2020
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 (51672-1381). Click a package code to view its specific billing and regulatory data.

51672-1381-4
1 KIT in 1 CARTON * 10 g in 1 BOTTLE, PLASTIC (51672-1382-2) * 40 g in 1 JAR
51672-1381-5
1 KIT in 1 CARTON * 7 g in 1 BOTTLE, PLASTIC (51672-1382-3) * 28 g in 1 BOTTLE, PUMP
51672-1381-6
1 KIT in 1 CARTON * 10 g in 1 BOTTLE, PLASTIC (51672-1382-2) * 40 g in 1 BOTTLE, PUMP

* 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 51672-1381-2 identifies a specific commercial package of 1 kit in 1 carton * 5 g in 1 bottle, plastic (51672-1382-1) * 20 g in 1 jar of Clindamycin Phosphate And Benzoyl Peroxide, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This kit is formulated for use and contains 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 January 21, 2020. 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: 51672138102. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
51672-1381-2
11-Digit CMS (5-4-2)
51672-1381-02

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