Palynziq Injection, Solution
NDC Package 68135-673-45

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Palynziq (pegvaliase-pqpz) injection is a medication used by people with a certain inherited condition (phenylketonuria) to reduce high levels of a certain substance (phenylalanine) that builds up in the blood. This formulation utilizes a injection, solution delivery system. Marketed by Biomarin Pharmaceutical Inc., this product is identified by NDC 68135-673 and is authorized under FDA application BLA761079.

Identification & Billing

NDC Package Code
68135-673-45
Package Description
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (68135-673-39)
Product Code
68135-673
11-Digit Billing Format
68135067345
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Palynziq
Non-Proprietary Name
Pegvaliase-pqpz
Substance Name
Pegvaliase
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.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PEGVALIASE 20 mg/mL
Pharmacologic Class
Usage Information
This medication is used by people with a certain inherited condition (phenylketonuria) to reduce high levels of a certain substance (phenylalanine) that builds up in the blood. Having high levels of phenylalanine in the blood may cause brain damage, heart problems, an abnormally small head size, and behavioral problems. Pegvaliase-pqpz works by breaking down phenylalanine in the blood. Along with using this medication, you should follow a special diet to control your blood phenylalanine levels. Ask your doctor for details.

Regulatory & Marketing

Labeler Name
Biomarin Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761079
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-24-2018
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68135-673). Click a package code to view its specific billing and regulatory data.

68135-673-40
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (68135-673-39)

* 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 68135-673-45 identifies a specific commercial package of 10 syringe in 1 carton / 1 ml in 1 syringe (68135-673-39) of Palynziq, a human prescription drug labeled by Biomarin Pharmaceutical Inc.. This injection, solution is formulated for subcutaneous use and contains pegvaliase 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 Biomarin Pharmaceutical Inc. on May 24, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used by people with a certain inherited condition (phenylketonuria) to reduce high levels of a certain substance (phenylalanine) that builds up in the blood. Having high levels of phenylalanine in the blood may cause brain damage, heart problems, an abnormally small head size, and behavioral problems. Pegvaliase-pqpz works by breaking down phenylalanine in the blood. Along with using this medication, you should follow a special diet to control your blood phenylalanine levels. Ask your doctor for details.

How is this Biomarin Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68135067345. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
68135-673-45
11-Digit CMS (5-4-2)
68135-0673-45

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