Somatropin Injection, Solution
NDC Package 68594-040-99

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 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 Boehringer Ingelheim Rcv Gmbh & Co Kg, this product is identified by NDC 68594-040.

Identification & Billing

NDC Package Code
68594-040-99
Package Description
1 mg in 1 BOTTLE
Product Code
68594-040
11-Digit Billing Format
68594004099

Clinical Specifications

Proprietary Name
Somatropin
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.
Active Ingredient(s)
SOMATROPIN 980 ug/mg
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
Boehringer Ingelheim Rcv Gmbh & Co Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
09-03-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68594-040-99 identifies a specific commercial package of 1 mg in 1 bottle of Somatropin (UNFINISHED drug), a bulk ingredient labeled by Boehringer Ingelheim Rcv Gmbh & Co Kg. This injection, 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 Boehringer Ingelheim Rcv Gmbh & Co Kg on September 03, 2020. The current certification is valid through December 31, 2026.

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 Boehringer Ingelheim Rcv Gmbh & Co Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68594004099. 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)
68594-040-99
11-Digit CMS (5-4-2)
68594-0040-99

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