Ammonium Lactate Lotion
NDC Package 45802-419-54

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

Ammonium Lactate lotions is a medication used to treat dry, scaly skin conditions (e.g., xerosis, ichthyosis vulgaris) and can also help relieve itching from these conditions. This formulation utilizes a lotion delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-419 and is authorized under FDA application ANDA075570.

Identification & Billing

NDC Package Code
45802-419-54
Package Description
225 g in 1 BOTTLE, PLASTIC
Product Code
45802-419
11-Digit Billing Format
45802041954
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
Non-Proprietary Name
Ammonium Lactate
Substance Name
Ammonium Lactate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
AMMONIUM LACTATE 12 g/100g
Pharmacologic Class
Acidifying Activity - [MoA] (Mechanism of Action)
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
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA075570
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-20-2006
Listing Expiration
12-31-2026
Exclude Flag
N
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 (45802-419). Click a package code to view its specific billing and regulatory data.

45802-419-26
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 45802-419-54 identifies a specific commercial package of 225 g in 1 bottle, plastic of Ammonium Lactate, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This lotion is formulated for topical use and contains ammonium lactate 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 Padagis Israel Pharmaceuticals Ltd on June 20, 2006. The current certification is valid through December 31, 2026.

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 Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802041954. 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 (5-3-2)
45802-419-54
11-Digit CMS (5-4-2)
45802-0419-54

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