Calendula Diaper Rash Cream
NDC Package 0164-2189-53

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Calendula Diaper Rash Cream is usesOffers temporary, quick and effective relief for minor skin irritations due to diaper rash.Minor skin irritations.Reliable protection from dampness. Marketed by Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled, this product is identified by NDC 0164-2189 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
0164-2189-53
Package Description
81 g in 1 TUBE
Product Code
0164-2189
11-Digit Billing Format
00164218953
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calendula Diaper Rash Cream
Dosage Form
-
Usage Information
UsesOffers temporary, quick and effective relief for minor skin irritations due to diaper rash.Minor skin irritations.Reliable protection from dampness.

Regulatory & Marketing

Labeler Name
Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-27-2013
Listing Expiration
12-31-2017
Exclude Flag
I
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 (0164-2189). Click a package code to view its specific billing and regulatory data.

0164-2189-49
1.5 g in 1 POUCH
0164-2189-54
10.8 g in 1 TUBE

* 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 0164-2189-53 identifies a specific commercial package of 81 g in 1 tube of Calendula Diaper Rash Cream, labeled by Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled. 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 Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled on June 27, 2013. The current certification is valid through December 31, 2017.

How is this Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00164218953. 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)
0164-2189-53
11-Digit CMS (5-4-2)
00164-2189-53

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