Somavert
NDC Package 0009-5199-01

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.

Somavert is pegvisomant is used to treat a certain condition called acromegaly. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-5199 and is authorized under FDA application BLA021106.

Identification & Billing

NDC Package Code
0009-5199-01
Package Description
1 KIT in 1 PACKAGE * 1 mL in 1 VIAL, SINGLE-DOSE (0009-5201-04) * 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
0009-5199
11-Digit Billing Format
00009519901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Somavert
Dosage Form
-
Usage Information
Pegvisomant is used to treat a certain condition called acromegaly. Acromegaly occurs when the body makes too much growth hormone and other natural substances such as insulin-like growth factor-I (IGF-I). Pegvisomant is usually used if you have not responded to other treatments (such as surgery, radiation, other medications). Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Pegvisomant works by blocking the action of growth hormone and by reducing the amount of IGF-I to normal levels.

Regulatory & Marketing

Labeler Name
Pharmacia & Upjohn Company Llc
FDA Application #
BLA021106
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-31-2014
End Marketing Date
01-31-2019
Listing Expiration
01-31-2019
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 0009-5199-01 identifies a specific commercial package of 1 kit in 1 package * 1 ml in 1 vial, single-dose (0009-5201-04) * 1 ml in 1 vial, single-dose of Somavert, labeled by Pharmacia & Upjohn Company Llc. 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 Pharmacia & Upjohn Company Llc on July 31, 2014. The current certification is valid through January 31, 2019.

What are the primary indications for this medication?

Pegvisomant is used to treat a certain condition called acromegaly. Acromegaly occurs when the body makes too much growth hormone and other natural substances such as insulin-like growth factor-I (IGF-I). Pegvisomant is usually used if you have not responded to other treatments (such as surgery, radiation, other medications). Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Pegvisomant works by blocking the action of growth hormone and by reducing the amount of IGF-I to normal levels.

How is this Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009519901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
0009-5199-01
11-Digit CMS (5-4-2)
00009-5199-01

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