Ammonium Lactate
NDC Package 0574-2121-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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 Paddock Laboratories, Llc, this product is identified by NDC 0574-2121 and is authorized under FDA application ANDA076829.

Identification & Billing

NDC Package Code
0574-2121-28
Package Description
2 TUBE in 1 CARTON / 140 g in 1 TUBE
Product Code
11-Digit Billing Format
00574212128
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
140 GM

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
Paddock Laboratories, Llc
FDA Application #
ANDA076829
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-07-2006
End Marketing Date
03-31-2012
Listing Expiration
03-31-2012
Exclude Flag
D
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 (0574-2121). Click a package code to view its specific billing and regulatory data.

385 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 0574-2121-28 identifies a specific commercial package of 2 tube in 1 carton / 140 g in 1 tube of Ammonium Lactate, labeled by Paddock Laboratories, Llc. This product is billed per "GM" gram and contains an estimated amount of 140 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 Paddock Laboratories, Llc on February 07, 2006. The current certification is valid through March 31, 2012.

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 Paddock Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574212128. 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 (4-4-2)
0574-2121-28
11-Digit CMS (5-4-2)
00574-2121-28

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