Clindamycin Phosphate Solution
NDC Package 45802-263-93

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 solution is a medication used to treat acne. This formulation utilizes a solution delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-263 and is authorized under FDA application ANDA065049.

Identification & Billing

NDC Package Code
45802-263-93
Package Description
69 APPLICATOR in 1 JAR / 1 mL in 1 APPLICATOR
Product Code
45802-263
11-Digit Billing Format
45802026393
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Phosphate
Non-Proprietary Name
Clindamycin Phosphate
Substance Name
Clindamycin Phosphate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
CLINDAMYCIN PHOSPHATE 10 mg/mL
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA065049
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45802-263). Click a package code to view its specific billing and regulatory data.

45802-263-37
60 APPLICATOR in 1 JAR / 1 mL in 1 APPLICATOR

* 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 45802-263-93 identifies a specific commercial package of 69 applicator in 1 jar / 1 ml in 1 applicator of Clindamycin Phosphate, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This solution is formulated for topical 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 Padagis Israel Pharmaceuticals Ltd on May 31, 2006. 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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802026393. 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)
45802-263-93
11-Digit CMS (5-4-2)
45802-0263-93

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