Pegvisomant Injection, Powder, Lyophilized, For Solution
NDC Package 59267-5201-4

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.

Pegvisomant injection is pegvisomant is used to treat a certain condition called acromegaly. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Pfizer Manufacturing Belgium Nv, this product is identified by NDC 59267-5201.

Identification & Billing

NDC Package Code
59267-5201-4
Package Description
1 mL in 1 VIAL, SINGLE-DOSE
Product Code
59267-5201
11-Digit Billing Format
59267520104

Clinical Specifications

Proprietary Name
Pegvisomant
Non-Proprietary Name
Pegvisomant
Substance Name
Pegvisomant
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Active Ingredient(s)
PEGVISOMANT 25 mg/mL
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
Pfizer Manufacturing Belgium Nv
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
07-31-2014
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 59267-5201-4 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Pegvisomant (UNFINISHED drug), drug for further processing labeled by Pfizer Manufacturing Belgium Nv. This injection, powder, lyophilized, for solution is formulated for use and contains pegvisomant 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 Pfizer Manufacturing Belgium Nv on July 31, 2014. The current certification is valid through December 31, 2026.

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 Pfizer Manufacturing Belgium Nv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59267520104. 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 (5-4-1)
59267-5201-4
11-Digit CMS (5-4-2)
59267-5201-04

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