Ammonium Lactate Cream
NDC Package 72578-203-11

11-digit billing NDC: 72578020311
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ammonium Lactate cream 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 cream delivery system. Marketed by Viona Pharmaceuticals Inc, this product is identified by NDC 72578-203 and is authorized under FDA application ANDA217815.

Identification & Billing

NDC Package Code
72578-203-11
Package Description
385 g in 1 BOTTLE
Product Code
72578-203
11-Digit Billing Format
72578020311

Clinical Specifications

Proprietary Name
Ammonium Lactate
Non-Proprietary Name
Ammonium Lactate
Substance Name
Ammonium Lactate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 120 mg/g
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
Viona Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA217815
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-02-2026
Listing Expiration
12-31-2027
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 (72578-203). Click a package code to view its specific billing and regulatory data.

72578-203-10
2 TUBE in 1 CARTON / 140 g in 1 TUBE (72578-203-13)

* 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 72578-203-11 identifies a specific commercial package of 385 g in 1 bottle of Ammonium Lactate, a human prescription drug labeled by Viona Pharmaceuticals Inc. This cream 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 Viona Pharmaceuticals Inc on October 02, 2026. The current certification is valid through December 31, 2027.

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 Viona Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72578020311. 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)
72578-203-11
11-Digit CMS (5-4-2)
72578-0203-11

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