Omnitrope Injection, Solution
NDC Package 0781-3004-07

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

Omnitrope (somatropin) injection 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. This formulation utilizes a injection, solution delivery system. Marketed by Sandoz Inc, this product is identified by NDC 0781-3004 and is authorized under FDA application BLA021426.

Identification & Billing

NDC Package Code
0781-3004-07
Package Description
1 CARTRIDGE in 1 CARTON / 1.5 mL in 1 CARTRIDGE
Product Code
0781-3004
11-Digit Billing Format
00781300407
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Omnitrope
Non-Proprietary Name
Somatropin
Substance Name
Somatropin
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.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SOMATROPIN 10 mg/1.5mL
Pharmacologic Class
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
Product Type
Human Prescription Drug
FDA Application #
BLA021426
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-30-2006
Listing Expiration
12-31-2027
Exclude Flag
N
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 (0781-3004). Click a package code to view its specific billing and regulatory data.

0781-3004-26
5 CARTRIDGE in 1 CARTON / 1.5 mL in 1 CARTRIDGE

* 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 0781-3004-07 identifies a specific commercial package of 1 cartridge in 1 carton / 1.5 ml in 1 cartridge of Omnitrope, a human prescription drug labeled by Sandoz Inc. This injection, solution is formulated for subcutaneous use and contains somatropin 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 Sandoz Inc on May 30, 2006. The current certification is valid through December 31, 2027.

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: 00781300407. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0781-3004-07
11-Digit CMS (5-4-2)
00781-3004-07

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