Cleocin Cream
NDC Package 0009-3448-01

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

Package Information

Cleocin (clindamycin phosphate) cream is a medication used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. This formulation utilizes a cream delivery system. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-3448 and is authorized under FDA application NDA050680.

Identification & Billing

NDC Package Code
0009-3448-01
Package Description
1 TUBE, WITH APPLICATOR in 1 CARTON / 40 g in 1 TUBE, WITH APPLICATOR
Product Code
0009-3448
11-Digit Billing Format
00009344801
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
Cleocin
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 a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
Pharmacia & Upjohn Company Llc
Product Type
Human Prescription Drug
FDA Application #
NDA050680
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-11-1992
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 0009-3448-01 identifies a specific commercial package of 1 tube, with applicator in 1 carton / 40 g in 1 tube, with applicator of Cleocin, a human prescription drug labeled by Pharmacia & Upjohn Company 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 Pharmacia & Upjohn Company Llc on August 11, 1992. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

How is this Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009344801. 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)
0009-3448-01
11-Digit CMS (5-4-2)
00009-3448-01

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