OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Plegridy

peginterferon beta-1a · Injection, Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Plegridy
Generic name
peginterferon beta-1a
Dosage form
Injection, Solution
Route
Intramuscular
Marketing category
BLA · BLA
Labeler
Biogen Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
Packages
3
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Peginterferon Beta-1A 125 ug/.5mL 1546172 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Intramuscular
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Interferon beta [EPC] EPC 3 members — no class page
Interferon-beta [CS] CS 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
125499
Application type
BLA · Biologics License Application
Approval date
August 15, 2014
Sponsor
BIOGEN IDEC INC
Products on application
1
Submissions recorded
9
Products approved under application 125499.
Product Trade name Form Strength Ingredient Status TE Flags
125499-001 PLEGRIDY INJECTABLE PEGINTERFERON BETA-1A Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 125499.
Type No. Action Status Date Review
Supplement 28 Labeling Approved July 28, 2023 Standard
Supplement 25 Labeling Approved March 29, 2022 Standard
Supplement 23 Labeling Approved November 3, 2021 Standard
Supplement 21 Efficacy Approved January 29, 2021 Standard
Supplement 18 Efficacy Approved March 27, 2020 Standard
Supplement 19 Labeling Approved July 10, 2019 Standard
Supplement 11 Labeling Approved July 14, 2016 Standard
Supplement 9 Labeling Approved December 22, 2015 Standard
Original application 1 Type 1 - New Molecular Entity Approved August 15, 2014 Standard

Review documents

  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · July 31, 2023
  • 0 · Supplement · March 31, 2022
  • 0 · Supplement · March 30, 2022
  • 0 · Supplement · November 5, 2021
  • 0 · Supplement · November 5, 2021
  • 0 · Supplement · February 2, 2021
  • 0 · Supplement · January 29, 2021
  • 0 · Supplement · March 31, 2020
  • 0 · Supplement · March 30, 2020
  • 0 · Supplement · July 12, 2019
  • 0 · Supplement · July 11, 2019
  • 0 · Supplement · July 18, 2016
  • 0 · Supplement · July 15, 2016
  • 0 · Supplement · December 28, 2015
  • 0 · Supplement · December 23, 2015
  • 0 · Original application · September 17, 2014
  • 0 · Original application · September 17, 2014
  • 0 · Original application · August 18, 2014
  • 0 · Original application · August 18, 2014

Adverse event reports

Source: openFDA FAERS
13,031
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PEGINTERFERON BETA-1A. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
64406-011-01 64406-011 Biogen Inc. 1 TRAY in 1 CARTON (64406-011-01) / 2 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE (64406-011-02) August 15, 2014
64406-015-01 64406-015 Biogen Inc. 1 TRAY in 1 CARTON (64406-015-01) / 2 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE (64406-015-02) August 15, 2014
64406-017-01 64406-017 Biogen Inc. 1 TRAY in 1 CARTON (64406-017-01) / 2 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE (64406-017-02) January 29, 2021
64406-011 64406-011 Biogen Inc. — August 15, 2014
64406-015 64406-015 Biogen Inc. — August 15, 2014
64406-017 64406-017 Biogen Inc. — January 29, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 10 sections on this page.