Pegvisomant Paste
NDC Package 64052-001-01

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 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 pastes is pegvisomant is used to treat a certain condition called acromegaly. This formulation utilizes a paste delivery system. Marketed by Pfizer Ireland Pharmaceuticals Unlimited Company, this product is identified by NDC 64052-001.

Identification & Billing

NDC Package Code
64052-001-01
Package Description
1850 g in 1 BOTTLE
Product Code
64052-001
11-Digit Billing Format
64052000101

Clinical Specifications

Proprietary Name
Pegvisomant
Non-Proprietary Name
Pegvisomant
Substance Name
Pegvisomant
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Active Ingredient(s)
PEGVISOMANT 1 g/g
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 Ireland Pharmaceuticals Unlimited Company
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-20-2014
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 64052-001-01 identifies a specific commercial package of 1850 g in 1 bottle of Pegvisomant (UNFINISHED drug), a bulk ingredient labeled by Pfizer Ireland Pharmaceuticals Unlimited Company. This paste 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 Ireland Pharmaceuticals Unlimited Company on February 20, 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 Ireland Pharmaceuticals Unlimited Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64052000101. 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)
64052-001-01
11-Digit CMS (5-4-2)
64052-0001-01

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