Clindamycin Phosphate And Benzoyl Peroxide Gel
NDC Package 68682-133-50

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 Oceanside Pharmaceuticals, this product is identified by NDC 68682-133 and is authorized under FDA application NDA050819.

Identification & Billing

NDC Package Code
68682-133-50
Package Description
1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP
Product Code
68682-133
11-Digit Billing Format
68682013350
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk
  • RxCUI: 1598470 - clindamycin phosphate 1.2 % / benzoyl peroxide 3.75 % Topical Gel
  • RxCUI: 1598470 - benzoyl peroxide 0.0375 MG/MG / clindamycin phosphate 0.012 MG/MG Topical Gel
  • RxCUI: 1598470 - benzoyl peroxide 3.75 % / clindamycin phosphate 1.2 % (clindamycin 1 % ) Topical Gel

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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA050819
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-02-2023
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 68682-133-50 identifies a specific commercial package of 1 bottle, pump in 1 carton / 50 g in 1 bottle, pump of Clindamycin Phosphate And Benzoyl Peroxide, a human prescription drug labeled by Oceanside Pharmaceuticals. 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 Oceanside Pharmaceuticals on October 02, 2023. The current certification is valid through December 31, 2026.

How is this Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682013350. 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 (5-3-2)
68682-133-50
11-Digit CMS (5-4-2)
68682-0133-50

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