FDA.reportPublic FDA data

Plegridy

Product NDC
64406-015
11-digit product format
644060015
Labeler code
64406
Product ID
64406-015_54502b45-bfe3-49ab-8992-32b5639dc8b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
peginterferon beta-1a
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Biogen Inc.
Application
BLA125499
Marketing category
BLA
Marketing start
2014-08-15
Substance
PEGINTERFERON BETA-1A
Active strength
125 ug/.5mL
Pharmacologic classes
Interferon beta [EPC], Interferon-beta [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plegridy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEGINTERFERON BETA-1A125 ug/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI8309403R0
Rxcui1546172, 1546177, 1546181, 1546183, 1546187, 1546189, 1546197, 1546198, 1649591, 1649593, 1649600, 1649601, 1649602, 1649603, 1649604, 1649605

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
37e5484b-6b53-4418-a871-c0b5dd2f2ed7Product name220191002
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64406-015-01Plegridy1 in 1 CARTONINJECTION, SOLUTION129
64406-015-01Plegridy2 in 1 TRAYINJECTION, SOLUTION229
64406-015-02Plegridy0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.529

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-015-01ML - Milliliter64406-01540a0f50b-9c08-49ee-a3be-126b25b7a13912014-11-05
64406-015-02ML - Milliliter64406-0151d6566db-a92d-43d6-975a-c5c2214a604012019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PEGINTERFERON BETA-1AACTIVE INGREDIENTI8309403R0PLEGRIDY (PEGINTERFERON BETA-1A) KIT PLEGRIDY PEN (PEGINTERFERON BETA-1A) KIT PLEGRIDY (PEGINTERFERON BETA-1A) INJECTION, SOLUTION [BIOGEN IDEC INC.]9
PEGINTERFERON BETA-1AACTIVE MOIETYI8309403R0PLEGRIDY (PEGINTERFERON BETA-1A) KIT PLEGRIDY PEN (PEGINTERFERON BETA-1A) KIT PLEGRIDY (PEGINTERFERON BETA-1A) INJECTION, SOLUTION [BIOGEN IDEC INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64406-015PLEGRIDY (PEGINTERFERON BETA-1A) INJECTION, SOLUTION PLEGRIDY PEN (PEGINTERFERON BETA-1A) INJECTION, SOLUTION PLEGRIDY (PEGINTERFERON BETA-1A) KIT [BIOGEN INC.]28Current NDC, Legacy NDC, 3 package rows20241116_08f0ea03-4e6d-195d-aef4-886e32befa95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649605{1 (0.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector [Plegridy]) / 1 (0.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector [Plegridy]) } Pack [Plegridy Pen Starter Pack]BPCK08f0ea03-4e6d-195d-aef4-886e32befa9529
1546198{1 (0.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe [Plegridy]) / 1 (0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe [Plegridy]) } Pack [Plegridy Starter Pack]BPCK08f0ea03-4e6d-195d-aef4-886e32befa9529
1649602{1 (0.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector) / 1 (0.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector) } PackGPCK08f0ea03-4e6d-195d-aef4-886e32befa9529
1546197{1 (0.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe) / 1 (0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe) } PackGPCK08f0ea03-4e6d-195d-aef4-886e32befa9529
1649591peginterferon beta-1a 125 MCG in 0.5 ML Auto-InjectorPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546187peginterferon beta-1a 125 MCG in 0.5 ML Prefilled SyringePSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649602peginterferon beta-1a 63 MCG in 0.5 ML (1) Auto-Injector / peginterferon beta-1a 94 MCG in 0.5 ML (1) Auto-Injector PackPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546197peginterferon beta-1a 63 MCG in 0.5 ML (1) Prefilled Syringe / peginterferon beta-1a 94 MCG in 0.5 ML (1) Prefilled Syringe PackPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649600peginterferon beta-1a 63 MCG in 0.5 ML Auto-InjectorPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546181peginterferon beta-1a 63 MCG in 0.5 ML Prefilled SyringePSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546172peginterferon beta-1a 94 MCG in 0.5 ML Prefilled SyringePSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649601peginterferon beta-1a 94 MCG per 0.5 ML Auto-InjectorPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649593Plegridy 125 MCG in 0.5 ML Auto-InjectorPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546189Plegridy 125 MCG in 0.5 ML Prefilled SyringePSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649603Plegridy 63 MCG in 0.5 ML Auto-InjectorPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546183Plegridy 63 MCG in 0.5 ML Prefilled SyringePSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649604Plegridy 94 MCG in 0.5 ML Auto-InjectorPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546177Plegridy 94 MCG in 0.5 ML Prefilled SyringePSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1649605Plegridy Pen Starter PackPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
1546198Plegridy Starter PackPSN08f0ea03-4e6d-195d-aef4-886e32befa9529
16496030.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector [Plegridy]SBD08f0ea03-4e6d-195d-aef4-886e32befa9529
15461830.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe [Plegridy]SBD08f0ea03-4e6d-195d-aef4-886e32befa9529
16496040.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector [Plegridy]SBD08f0ea03-4e6d-195d-aef4-886e32befa9529
15461770.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe [Plegridy]SBD08f0ea03-4e6d-195d-aef4-886e32befa9529
16495930.5 ML peginterferon beta-1a 0.25 MG/ML Auto-Injector [Plegridy]SBD08f0ea03-4e6d-195d-aef4-886e32befa9529
15461890.5 ML peginterferon beta-1a 0.25 MG/ML Prefilled Syringe [Plegridy]SBD08f0ea03-4e6d-195d-aef4-886e32befa9529
16496000.5 ML peginterferon beta-1a 0.126 MG/ML Auto-InjectorSCD08f0ea03-4e6d-195d-aef4-886e32befa9529
15461810.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled SyringeSCD08f0ea03-4e6d-195d-aef4-886e32befa9529
16496010.5 ML peginterferon beta-1a 0.188 MG/ML Auto-InjectorSCD08f0ea03-4e6d-195d-aef4-886e32befa9529
15461720.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled SyringeSCD08f0ea03-4e6d-195d-aef4-886e32befa9529
16495910.5 ML peginterferon beta-1a 0.25 MG/ML Auto-InjectorSCD08f0ea03-4e6d-195d-aef4-886e32befa9529
15461870.5 ML peginterferon beta-1a 0.25 MG/ML Prefilled SyringeSCD08f0ea03-4e6d-195d-aef4-886e32befa9529
16496030.5 ML Plegridy 0.126 MG/ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
15461830.5 ML Plegridy 0.126 MG/ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
16496040.5 ML Plegridy 0.188 MG/ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
15461770.5 ML Plegridy 0.188 MG/ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
16495930.5 ML Plegridy 0.25 MG/ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546181peginterferon beta-1a 0.063 MG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546187peginterferon beta-1a 0.125 MG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649591peginterferon beta-1a 125 MCG per 0.5 ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546187peginterferon beta-1a 125 MCG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649600peginterferon beta-1a 63 MCG per 0.5 ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546181peginterferon beta-1a 63 MCG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649601peginterferon beta-1a 94 MCG per 0.5 ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546172peginterferon beta-1a 94 MCG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546189Plegridy 0.125 MG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649593Plegridy 125 MCG per 0.5 ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546189Plegridy 125 MCG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649603Plegridy 63 MCG per 0.5 ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546183Plegridy 63 MCG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649604Plegridy 94 MCG per 0.5 ML Auto-InjectorSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546177Plegridy 94 MCG per 0.5 ML Prefilled SyringeSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1649605Plegridy Pen Starter PackSY08f0ea03-4e6d-195d-aef4-886e32befa9529
1546198Plegridy Starter PackSY08f0ea03-4e6d-195d-aef4-886e32befa9529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64406-015-01644060015011 TRAY in 1 CARTON (64406-015-01) / 2 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE (64406-015-02) 1 tray2014-08-150000-00-00NoNoCurrent
64406-015-02644060015020.5 mL in 1 SYRINGE0.5 mlHistorical