Totect
NDC Package 38423-110-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Totect is a . Marketed by Topotarget Usa, this product is identified by NDC 38423-110 and is authorized under FDA application NDA022025.

Identification & Billing

NDC Package Code
38423-110-01
Package Description
1 KIT in 1 BOX * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE * 1 INJECTION, SOLUTION, CONCENTRATE in 1 VIAL, SINGLE-USE
Product Code
38423-110
11-Digit Billing Format
38423011001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Totect
Dosage Form
-

Regulatory & Marketing

Labeler Name
Topotarget Usa
FDA Application #
NDA022025
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-16-2007
End Marketing Date
07-31-2014
Listing Expiration
07-31-2014
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage
  • 38423 - Topotarget Usa
    • 38423-110 - Totect
      • 38423-110-01 - 1 KIT in 1 BOX * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE * 1 INJECTION, SOLUTION, CONCENTRATE in 1 VIAL, SINGLE-USE

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 38423-110-01 identifies a specific commercial package of 1 kit in 1 box * 1 injection, powder, lyophilized, for solution in 1 vial, single-use * 1 injection, solution, concentrate in 1 vial, single-use of Totect, labeled by Topotarget Usa. 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 Topotarget Usa on October 16, 2007. The current certification is valid through July 31, 2014.

How is this Topotarget Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 38423011001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
38423-110-01
11-Digit CMS (5-4-2)
38423-0110-01

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