Clindamycin Phosphate Cream
NDC Package 0168-0277-40

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

Package Information

Clindamycin Phosphate cream is a medication used to treat acne. This formulation utilizes a cream delivery system. Marketed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc, this product is identified by NDC 0168-0277 and is authorized under FDA application ANDA065139.

Identification & Billing

NDC Package Code
0168-0277-40
Package Description
40 g in 1 TUBE, WITH APPLICATOR
Product Code
0168-0277
11-Digit Billing Format
00168027740
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
40 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Phosphate
Non-Proprietary Name
Clindamycin Phosphate
Substance Name
Clindamycin Phosphate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
CLINDAMYCIN PHOSPHATE 20 mg/g
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
E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065139
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2004
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0168-0277-40 identifies a specific commercial package of 40 g in 1 tube, with applicator of Clindamycin Phosphate, a human prescription drug labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc. This cream is formulated for vaginal 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc on December 27, 2004. 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168027740. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 40 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 (4-4-2)
0168-0277-40
11-Digit CMS (5-4-2)
00168-0277-40

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