Omnitrope
NDC Package 0781-4002-32

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.

Omnitrope is various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting. Marketed by Sandoz Inc, this product is identified by NDC 0781-4002 and is authorized under FDA application NDA021426.

Identification & Billing

NDC Package Code
0781-4002-32
Package Description
1 KIT in 1 CARTON * 1.13 mL in 1 VIAL * 1.13 mL in 1 VIAL
Product Code
0781-4002
11-Digit Billing Format
00781400232

Clinical Specifications

Proprietary Name
Omnitrope
Dosage Form
-
Usage Information
Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting. Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).

Regulatory & Marketing

Labeler Name
Sandoz Inc
FDA Application #
NDA021426
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-30-2006
End Marketing Date
09-29-2014
Listing Expiration
09-29-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0781-4002-32 identifies a specific commercial package of 1 kit in 1 carton * 1.13 ml in 1 vial * 1.13 ml in 1 vial of Omnitrope, labeled by Sandoz Inc. 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 Sandoz Inc on May 30, 2006. The current certification is valid through September 29, 2014.

What are the primary indications for this medication?

Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting. Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781400232. 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)
0781-4002-32
11-Digit CMS (5-4-2)
00781-4002-32

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