Ammonium Lactate
NDC Package 63044-404-20

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 inactivated by the FDA.

Ammonium Lactate is a medication used to treat dry, scaly skin conditions (e.g., xerosis, ichthyosis vulgaris) and can also help relieve itching from these conditions. Marketed by Nnodum Pharmaceuticals, this product is identified by NDC 63044-404 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
63044-404-20
Package Description
140 g in 1 TUBE
Product Code
63044-404
11-Digit Billing Format
63044040420
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
140 GM
RxNorm Crosswalk
  • RxCUI: 543460 - ammonium lactate 12 % Topical Cream
  • RxCUI: 543460 - ammonium lactate 120 MG/ML Topical Cream
  • RxCUI: 543460 - ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Cream

Clinical Specifications

Proprietary Name
Ammonium Lactate
Dosage Form
-
Usage Information
This medication is used to treat dry, scaly skin conditions (e.g., xerosis, ichthyosis vulgaris) and can also help relieve itching from these conditions. This medication works by increasing the moisture in the skin.

Regulatory & Marketing

Labeler Name
Nnodum Pharmaceuticals
FDA Application #
part334
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
12-30-2007
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63044-404-20 identifies a specific commercial package of 140 g in 1 tube of Ammonium Lactate, labeled by Nnodum Pharmaceuticals. 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 Nnodum Pharmaceuticals on December 30, 2007. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat dry, scaly skin conditions (e.g., xerosis, ichthyosis vulgaris) and can also help relieve itching from these conditions. This medication works by increasing the moisture in the skin.

How is this Nnodum Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63044040420. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 140 total billable units per package. 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)
63044-404-20
11-Digit CMS (5-4-2)
63044-0404-20

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