Lcz696 Injection, Solution
NDC Package 52076-6259-2

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Lcz696 injection is teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. This formulation utilizes a injection, solution delivery system. Marketed by Chunghwa Chemical Synthesis & Biotech. Ltd, this product is identified by NDC 52076-6259.

Identification & Billing

NDC Package Code
52076-6259-2
Package Description
50 kg in 1 VIAL, GLASS
Product Code
52076-6259
11-Digit Billing Format
52076625902

Clinical Specifications

Proprietary Name
Lcz696
Non-Proprietary Name
Lcz696
Substance Name
Teduglutide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
TEDUGLUTIDE 1 kg/kg
Usage Information
Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2). It works by helping to improve intestinal absorption of fluids and nutrients.

Regulatory & Marketing

Labeler Name
Chunghwa Chemical Synthesis & Biotech. Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-22-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (52076-6259). Click a package code to view its specific billing and regulatory data.

52076-6259-1
5 kg in 1 VIAL, GLASS
52076-6259-3
200 kg in 1 VIAL, GLASS

* 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 52076-6259-2 identifies a specific commercial package of 50 kg in 1 vial, glass of Lcz696 (UNFINISHED drug), a bulk ingredient labeled by Chunghwa Chemical Synthesis & Biotech. Ltd. This injection, solution is formulated for use and contains teduglutide 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 Chunghwa Chemical Synthesis & Biotech. Ltd on February 22, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2). It works by helping to improve intestinal absorption of fluids and nutrients.

How is this Chunghwa Chemical Synthesis & Biotech. Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52076625902. 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 (5-4-1)
52076-6259-2
11-Digit CMS (5-4-2)
52076-6259-02

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