Rosadan
NDC Package 43538-183-45

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Rosadan is a medication used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. Marketed by Medimetriks Pharmaceuticals, Inc., this product is identified by NDC 43538-183 and is authorized under FDA application ANDA078178.

Identification & Billing

NDC Package Code
43538-183-45
Package Description
1 KIT in 1 CARTON * 1 TUBE in 1 CARTON / 45 g in 1 TUBE * 1 BOTTLE, PUMP in 1 CARTON / 454 g in 1 BOTTLE, PUMP
Product Code
43538-183
11-Digit Billing Format
43538018345
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Rosadan
Dosage Form
-
Usage Information
This medication is used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It may help to decrease redness, swelling and the number of pimples caused by rosacea. This medication is an antibiotic. For the treatment of rosacea, metronidazole is believed to work by decreasing swelling (inflammation). Some brands of this medication also contain sunscreens (see also Notes section).

Regulatory & Marketing

Labeler Name
Medimetriks Pharmaceuticals, Inc.
FDA Application #
ANDA078178
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-01-2011
End Marketing Date
11-01-2022
Listing Expiration
11-01-2022
Exclude Flag
D
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 43538-183-45 identifies a specific commercial package of 1 kit in 1 carton * 1 tube in 1 carton / 45 g in 1 tube * 1 bottle, pump in 1 carton / 454 g in 1 bottle, pump of Rosadan, labeled by Medimetriks Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medimetriks Pharmaceuticals, Inc. on August 01, 2011. The current certification is valid through November 01, 2022.

What are the primary indications for this medication?

This medication is used on the skin to treat a certain skin disorder known as rosacea, a type of adult acne. It may help to decrease redness, swelling and the number of pimples caused by rosacea. This medication is an antibiotic. For the treatment of rosacea, metronidazole is believed to work by decreasing swelling (inflammation). Some brands of this medication also contain sunscreens (see also Notes section).

How is this Medimetriks Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43538018345. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
43538-183-45
11-Digit CMS (5-4-2)
43538-0183-45

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