Ammonium Lactate
NDC Package 54868-4599-0

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.

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 Physicians Total Care, Inc., this product is identified by NDC 54868-4599 and is authorized under FDA application ANDA075570.

Identification & Billing

NDC Package Code
54868-4599-0
Package Description
225 g in 1 BOTTLE, PLASTIC
Product Code
54868-4599
11-Digit Billing Format
54868459900
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
225 GM
RxNorm Crosswalk
  • RxCUI: 197362 - ammonium lactate 12 % Topical Lotion
  • RxCUI: 197362 - ammonium lactate 120 MG/ML Topical Lotion
  • RxCUI: 197362 - ammonium lactate 120 MG/ML (as neutralized lactic acid 12 % ) Topical Lotion

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
Physicians Total Care, Inc.
FDA Application #
ANDA075570
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2002
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 (54868-4599). Click a package code to view its specific billing and regulatory data.

54868-4599-1
400 g in 1 BOTTLE, PLASTIC

* 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 54868-4599-0 identifies a specific commercial package of 225 g in 1 bottle, plastic of Ammonium Lactate, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 225 billable units per package. 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 Physicians Total Care, Inc. on February 14, 2002. 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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868459900. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 225 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 (5-4-1)
54868-4599-0
11-Digit CMS (5-4-2)
54868-4599-00

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