plegridy pen

Generic: peginterferon beta-1a

Labeler: biogen inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name plegridy pen
Generic Name peginterferon beta-1a
Labeler biogen inc.
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Biogen Inc.

Identifiers & Regulatory

Product NDC 64406-012
Product ID 64406-012_54502b45-bfe3-49ab-8992-32b5639dc8b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125499
Listing Expiration 2026-12-31
Marketing Start 2014-08-15

Pharmacologic Class

Established (EPC)
interferon beta [epc]
Chemical Structure
interferon-beta [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64406012
Hyphenated Format 64406-012

Supplemental Identifiers

RxCUI
1546172 1546177 1546181 1546183 1546187 1546189 1546197 1546198 1649591 1649593 1649600 1649601 1649602 1649603 1649604 1649605
UNII
I8309403R0
NUI
M0025715 N0000191625

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name plegridy pen (source: ndc)
Generic Name peginterferon beta-1a (source: ndc)
Application Number BLA125499 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 125 mcg/0.5 ml
  • 63 mcg/0.5 ml
  • 94 mcg/0.5 ml
  • 0.5 ml
  • 63 mcg
  • 94 mcg
source: label
Packaging
  • 1 CARTON in 1 KIT (64406-012-01) / 1 KIT in 1 CARTON * .5 mL in 1 SYRINGE (64406-010-02) * .5 mL in 1 SYRINGE (64406-009-02)
source: ndc

Packages (1)

64406-012-01 1 CARTON in 1 KIT (64406-012-01) / 1 KIT in 1 CARTON * .5 mL in 1 SYRINGE (64406-010-02) * .5 mL in 1 SYRINGE (64406-009-02)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Plegridy Pen, Plegridy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "54502b45-bfe3-49ab-8992-32b5639dc8b6", "openfda": {"nui": ["M0025715", "N0000191625"], "unii": ["I8309403R0"], "rxcui": ["1546172", "1546177", "1546181", "1546183", "1546187", "1546189", "1546197", "1546198", "1649591", "1649593", "1649600", "1649601", "1649602", "1649603", "1649604", "1649605"], "spl_set_id": ["08f0ea03-4e6d-195d-aef4-886e32befa95"], "pharm_class_cs": ["Interferon-beta [CS]"], "pharm_class_epc": ["Interferon beta [EPC]"], "manufacturer_name": ["Biogen Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 KIT (64406-012-01)  / 1 KIT in 1 CARTON *  .5 mL in 1 SYRINGE (64406-010-02)  *  .5 mL in 1 SYRINGE (64406-009-02)", "package_ndc": "64406-012-01", "marketing_start_date": "20140815"}], "brand_name": "Plegridy Pen", "product_id": "64406-012_54502b45-bfe3-49ab-8992-32b5639dc8b6", "dosage_form": "KIT", "product_ndc": "64406-012", "generic_name": "peginterferon beta-1a", "labeler_name": "Biogen Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Plegridy", "brand_name_suffix": "Pen", "application_number": "BLA125499", "marketing_category": "BLA", "marketing_start_date": "20140815", "listing_expiration_date": "20261231"}