Plegridy Kit
NDC 64406-016

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 64406-016?
  4. Plegridy Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk
  7. Patient Education

Product Information

Plegridy (peginterferon beta-1a) is a BLA-approved product labeled by Biogen Inc.. This medication is used to treat multiple sclerosis (MS). It is supplied as a kit for subcutaneous administration. This product entry covers the primary NDC 64406-016 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64406-016
Proprietary Name:
Plegridy
Non-Proprietary Name: [1]
Peginterferon Beta-1a
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Biogen Inc.
Labeler Code:
64406
Product Label ID:
08f0ea03-4e6d-195d-aef4-886e32befa95
FDA Application Number: [6]
BLA125499
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
08-15-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 64406-016?

The NDC code 64406-016 is assigned by the FDA to the product Plegridy. It is commonly known by its generic name, peginterferon beta-1a. This pharmaceutical product is labeled by Biogen Inc. and is currently categorized as listed product. The medication is a kit administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 64406-016-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat multiple sclerosis (MS). Peginterferon is not a cure for MS, but it may help to decrease the number of episodes of disease worsening (relapses) and slow the worsening of the disease.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1546172 - peginterferon beta-1a 94 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 1546172 - 0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe
  • RxCUI: 1546172 - peginterferon beta-1a 94 MCG per 0.5 ML Prefilled Syringe
  • RxCUI: 1546177 - Plegridy 94 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 1546177 - 0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe [Plegridy]

* Please review the full disclaimer at the bottom of this page.

Patient Education

Peginterferon Alfa-2a Injection


Peginterferon alfa-2a is used alone or in combination with other medications to treat chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in people who show signs of liver damage. Peginterferon alfa-2a is also used to treat chronic hepatitis B infection (swelling of the liver caused by a virus) in people who show signs of liver damage. Peginterferon alfa-2a is in a class of medications called interferons. Peginterferon is a combination of interferon and polyethylene glycol, which helps the interferon stay active in your body for a longer period of time. Peginterferon works by decreasing the amount of hepatitis C virus (HCV) or hepatitis B virus (HBV) in the body. Peginterferon alfa-2a may not cure hepatitis C or hepatitis B or prevent you from developing complications of hepatitis C or hepatitis B such as cirrhosis (scarring) of the liver, liver failure, or liver cancer. Peginterferon alfa-2a may not prevent the spread of hepatitis C or hepatitis B to other people.
[Learn More]


Peginterferon Beta-1a Injection


Peginterferon beta-1a injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including the following: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Peginterferon beta-1a injection is in a class of medications called immunomodulators. It works by decreasing inflammation and preventing nerve damage that may cause symptoms of multiple sclerosis.
[Learn More]


Cancer Chemotherapy


What is cancer chemotherapy?

Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

Chemotherapy is used to:

  • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
  • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

What are the side effects of chemotherapy?

Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

Some common side effects are:

There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

What can I expect when getting chemotherapy?

You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

NIH: National Cancer Institute


[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".