Plegridy

Product NDC: 64406-012
11-digit product format: 644060012
Labeler code: 64406
Product ID: 64406-012_54502b45-bfe3-49ab-8992-32b5639dc8b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: peginterferon beta-1a
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: Biogen Inc.
Application: BLA125499
Marketing category: BLA
Marketing start: 2014-08-15
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Plegridy Pen	PEGINTERFERON BETA-1A	Biogen Inc.	08f0ea03-4e6d-195d-aef4-886e32befa95	2025-11-12	Warnings, Adverse reactions	Exact identifier application number: BLA125499 ndc (product): 64406-012

Additional Listing Data#

Finished product: Yes
Brand name base: Plegridy
Brand name suffix: Pen
Listing expiration: 2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I8309403R0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1546172	Internal RxNorm lookup
1546177	Internal RxNorm lookup
1546181	Internal RxNorm lookup
1546183	Internal RxNorm lookup
1546187	Internal RxNorm lookup
1546189	Internal RxNorm lookup
1546197	Internal RxNorm lookup
1546198	Internal RxNorm lookup
1649591	Internal RxNorm lookup
1649593	Internal RxNorm lookup
1649600	Internal RxNorm lookup
1649601	Internal RxNorm lookup
1649602	Internal RxNorm lookup
1649603	Internal RxNorm lookup
1649604	Internal RxNorm lookup
1649605	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
08f0ea03-4e6d-195d-aef4-886e32befa95	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
37e5484b-6b53-4418-a871-c0b5dd2f2ed7	Product name	2	20191002
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64406-009-02	PlegridyPen	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	1 mL	63 ug in 0.5mL	29
64406-010-02	PlegridyPen	0.5 mL in 1 SYRINGE	INJECTION, SOLUTION	1 mL	94 ug in 0.5mL	29
64406-012-01	PlegridyPen	1 in 1 KIT	KIT	1		29
64406-012-01	PlegridyPen	1 in 1 CARTON	KIT	1		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-012-01	ML - Milliliter	64406-012	a5984ca4-c954-4841-b5a6-8074edcc6231	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PEGINTERFERON BETA-1A	ACTIVE INGREDIENT	I8309403R0	PLEGRIDY (PEGINTERFERON BETA-1A) KIT PLEGRIDY PEN (PEGINTERFERON BETA-1A) KIT PLEGRIDY (PEGINTERFERON BETA-1A) INJECTION, SOLUTION [BIOGEN IDEC INC.]	9
PEGINTERFERON BETA-1A	ACTIVE MOIETY	I8309403R0	PLEGRIDY (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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64406-012	PLEGRIDY (PEGINTERFERON BETA-1A) INJECTION, SOLUTION PLEGRIDY PEN (PEGINTERFERON BETA-1A) INJECTION, SOLUTION PLEGRIDY (PEGINTERFERON BETA-1A) KIT [BIOGEN INC.]	28	Current NDC, Legacy NDC, 4 package rows	20241116_08f0ea03-4e6d-195d-aef4-886e32befa95.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125499	Plegridy	peginterferon beta-1a	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I8309403R0	PEGINTERFERON BETA-1A	1211327-92-2	peginterferon beta-1a

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL 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]	BPCK	08f0ea03-4e6d-195d-aef4-886e32befa95	29
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]	BPCK	08f0ea03-4e6d-195d-aef4-886e32befa95	29
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) } Pack	GPCK	08f0ea03-4e6d-195d-aef4-886e32befa95	29
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) } Pack	GPCK	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649591	peginterferon beta-1a 125 MCG in 0.5 ML Auto-Injector	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546187	peginterferon beta-1a 125 MCG in 0.5 ML Prefilled Syringe	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649602	peginterferon beta-1a 63 MCG in 0.5 ML (1) Auto-Injector / peginterferon beta-1a 94 MCG in 0.5 ML (1) Auto-Injector Pack	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546197	peginterferon beta-1a 63 MCG in 0.5 ML (1) Prefilled Syringe / peginterferon beta-1a 94 MCG in 0.5 ML (1) Prefilled Syringe Pack	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649600	peginterferon beta-1a 63 MCG in 0.5 ML Auto-Injector	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546181	peginterferon beta-1a 63 MCG in 0.5 ML Prefilled Syringe	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546172	peginterferon beta-1a 94 MCG in 0.5 ML Prefilled Syringe	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649601	peginterferon beta-1a 94 MCG per 0.5 ML Auto-Injector	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649593	Plegridy 125 MCG in 0.5 ML Auto-Injector	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546189	Plegridy 125 MCG in 0.5 ML Prefilled Syringe	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649603	Plegridy 63 MCG in 0.5 ML Auto-Injector	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546183	Plegridy 63 MCG in 0.5 ML Prefilled Syringe	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649604	Plegridy 94 MCG in 0.5 ML Auto-Injector	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546177	Plegridy 94 MCG in 0.5 ML Prefilled Syringe	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649605	Plegridy Pen Starter Pack	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546198	Plegridy Starter Pack	PSN	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649603	0.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector [Plegridy]	SBD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546183	0.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe [Plegridy]	SBD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649604	0.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector [Plegridy]	SBD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546177	0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe [Plegridy]	SBD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649593	0.5 ML peginterferon beta-1a 0.25 MG/ML Auto-Injector [Plegridy]	SBD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546189	0.5 ML peginterferon beta-1a 0.25 MG/ML Prefilled Syringe [Plegridy]	SBD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649600	0.5 ML peginterferon beta-1a 0.126 MG/ML Auto-Injector	SCD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546181	0.5 ML peginterferon beta-1a 0.126 MG/ML Prefilled Syringe	SCD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649601	0.5 ML peginterferon beta-1a 0.188 MG/ML Auto-Injector	SCD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546172	0.5 ML peginterferon beta-1a 0.188 MG/ML Prefilled Syringe	SCD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649591	0.5 ML peginterferon beta-1a 0.25 MG/ML Auto-Injector	SCD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546187	0.5 ML peginterferon beta-1a 0.25 MG/ML Prefilled Syringe	SCD	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649603	0.5 ML Plegridy 0.126 MG/ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546183	0.5 ML Plegridy 0.126 MG/ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649604	0.5 ML Plegridy 0.188 MG/ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546177	0.5 ML Plegridy 0.188 MG/ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649593	0.5 ML Plegridy 0.25 MG/ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546181	peginterferon beta-1a 0.063 MG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546187	peginterferon beta-1a 0.125 MG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649591	peginterferon beta-1a 125 MCG per 0.5 ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546187	peginterferon beta-1a 125 MCG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649600	peginterferon beta-1a 63 MCG per 0.5 ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546181	peginterferon beta-1a 63 MCG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649601	peginterferon beta-1a 94 MCG per 0.5 ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546172	peginterferon beta-1a 94 MCG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546189	Plegridy 0.125 MG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649593	Plegridy 125 MCG per 0.5 ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546189	Plegridy 125 MCG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649603	Plegridy 63 MCG per 0.5 ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546183	Plegridy 63 MCG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649604	Plegridy 94 MCG per 0.5 ML Auto-Injector	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546177	Plegridy 94 MCG per 0.5 ML Prefilled Syringe	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1649605	Plegridy Pen Starter Pack	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29
1546198	Plegridy Starter Pack	SY	08f0ea03-4e6d-195d-aef4-886e32befa95	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64406-009-02	64406000902	0.5 mL in 1 SYRINGE	0.5 ml					Historical
64406-010-02	64406001002	0.5 mL in 1 SYRINGE	0.5 ml					Historical
64406-012-01	64406001201	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)	1 carton	2014-08-15	0000-00-00	No	No	Current