NDC Package 0378-8688-35 Clindamycin Phosphate And Benzoyl Peroxide

Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0378-8688-35

Package Description:

1 KIT in 1 CARTON * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR

Product Code:

0378-8688

Proprietary Name:

Clindamycin Phosphate And Benzoyl Peroxide

Non-Proprietary Name:

Clindamycin Phosphate And Benzoyl Peroxide

Usage Information:

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.

11-Digit NDC Billing Format:

00378868835

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

RxCUI: 308694 - benzoyl peroxide 5 % Topical Gel

RxCUI: 308694 - benzoyl peroxide 0.05 MG/MG Topical Gel

RxCUI: 309333 - clindamycin phosphate 1 % Topical Solution

RxCUI: 309333 - clindamycin 10 MG/ML Topical Solution

RxCUI: 309333 - clindamycin (as clindamycin phosphate) 1 % Topical Solution

Product Type:

Human Prescription Drug

Labeler Name:

Mylan Pharmaceuticals Inc.

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

ANDA065443

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

08-25-2009

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0378 - Mylan Pharmaceuticals Inc.
- 0378-8688 - Clindamycin Phosphate And Benzoyl Peroxide
  - 0378-8688-35 - 1 KIT in 1 CARTON * 5 g in 1 BOTTLE, PLASTIC * 20 g in 1 JAR

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
0378-8688-54	1 KIT in 1 CARTON * 10 g in 1 BOTTLE, PLASTIC * 40 g in 1 JAR

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0378-8688-35?

The NDC Packaged Code 0378-8688-35 is assigned to a package of 1 kit in 1 carton * 5 g in 1 bottle, plastic * 20 g in 1 jar of Clindamycin Phosphate And Benzoyl Peroxide, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is kit and is administered via form.

Is NDC 0378-8688 included in the NDC Directory?

Yes, Clindamycin Phosphate And Benzoyl Peroxide with product code 0378-8688 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on August 25, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-8688-35?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight.

What is the 11-digit format for NDC 0378-8688-35?

The 11-digit format is 00378868835. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0378-8688-35	5-4-2	00378-8688-35

Table of Contents