Zinc Oxide Lotion
NDC Package 76446-044-01

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Zinc Oxide lotions is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a lotion delivery system. Marketed by Anna Lotan Ltd, this product is identified by NDC 76446-044.

Identification & Billing

NDC Package Code
76446-044-01
Package Description
100000 g in 1 DRUM
Product Code
76446-044
11-Digit Billing Format
76446004401

Clinical Specifications

Proprietary Name
Zinc Oxide
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Active Ingredient(s)
ZINC OXIDE 10900 mg/100g
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Anna Lotan Ltd
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-30-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (76446-044). Click a package code to view its specific billing and regulatory data.

76446-044-02
200000 g in 1 DRUM
76446-044-03
1000000 g in 1 DRUM

* 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 76446-044-01 identifies a specific commercial package of 100000 g in 1 drum of Zinc Oxide (UNFINISHED drug), drug for further processing labeled by Anna Lotan Ltd. This lotion is formulated for use and contains zinc oxide 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 Anna Lotan Ltd on November 30, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Anna Lotan Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76446004401. 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)
76446-044-01
11-Digit CMS (5-4-2)
76446-0044-01

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