Laclotion
NDC Package 0574-2021-08

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 discontinued by the firm.

Laclotion is a . Marketed by Paddock Laboratories, Llc, this product is identified by NDC 0574-2021 and is authorized under FDA application ANDA075575.

Identification & Billing

NDC Package Code
0574-2021-08
Package Description
225 g in 1 BOTTLE, PLASTIC
Product Code
0574-2021
11-Digit Billing Format
00574202108
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
225 GM

Clinical Specifications

Proprietary Name
Laclotion
Dosage Form
-

Regulatory & Marketing

Labeler Name
Paddock Laboratories, Llc
FDA Application #
ANDA075575
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-11-2002
End Marketing Date
09-30-2012
Listing Expiration
09-30-2012
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 (0574-2021). Click a package code to view its specific billing and regulatory data.

0574-2021-16
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 0574-2021-08 identifies a specific commercial package of 225 g in 1 bottle, plastic of Laclotion, labeled by Paddock Laboratories, Llc. 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 Paddock Laboratories, Llc on June 11, 2002. The current certification is valid through September 30, 2012.

How is this Paddock Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574202108. 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 (4-4-2)
0574-2021-08
11-Digit CMS (5-4-2)
00574-2021-08

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