Clindamycin Phoaphate Topical Solution Usp, 1% Solution
NDC Package 72603-321-01

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 Phoaphate Topical Solution Usp, 1% (clindamycin phosphate topical solution usp, 1%) solution is a medication used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. This formulation utilizes a solution delivery system. Marketed by Northstar Rx Llc, this product is identified by NDC 72603-321 and is authorized under FDA application ANDA209914.

Identification & Billing

NDC Package Code
72603-321-01
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
72603-321
11-Digit Billing Format
72603032101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Phoaphate Topical Solution Usp, 1%
Non-Proprietary Name
Clindamycin Phosphate Topical Solution Usp, 1%
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 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
Northstar Rx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209914
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-14-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72603-321). Click a package code to view its specific billing and regulatory data.

72603-321-02
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE

* 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 72603-321-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Clindamycin Phoaphate Topical Solution Usp, 1%, a human prescription drug labeled by Northstar Rx Llc. 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 Northstar Rx Llc on November 14, 2024. 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 Northstar Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72603032101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72603-321-01
11-Digit CMS (5-4-2)
72603-0321-01

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