Somatropin Powder, For Solution
NDC Package 62287-190-10

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 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.

Somatropin powders 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 powder, for solution delivery system. Marketed by Wasserburger Arzneimittelwerk Gmbh, this product is identified by NDC 62287-190.

Identification & Billing

NDC Package Code
62287-190-10
Package Description
8 TRAY in 1 BOX / 352 VIAL in 1 TRAY / 1 POWDER, FOR SOLUTION in 1 VIAL
Product Code
62287-190
11-Digit Billing Format
62287019010

Clinical Specifications

Proprietary Name
Somatropin
Non-Proprietary Name
Somatropin
Substance Name
Somatropin
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Active Ingredient(s)
SOMATROPIN 10 mg/1
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
Wasserburger Arzneimittelwerk Gmbh
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-04-2015
End Marketing Date
01-29-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62287-190-10 identifies a specific commercial package of 8 tray in 1 box / 352 vial in 1 tray / 1 powder, for solution in 1 vial of Somatropin (UNFINISHED drug), drug for further processing labeled by Wasserburger Arzneimittelwerk Gmbh. This powder, for solution is formulated for 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 Wasserburger Arzneimittelwerk Gmbh on March 04, 2015.

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 Wasserburger Arzneimittelwerk Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62287019010. 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)
62287-190-10
11-Digit CMS (5-4-2)
62287-0190-10

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