FDA.reportPublic FDA data

Avonex Pen

Product NDC
59627-003
11-digit product format
596270003
Labeler code
59627
Product ID
59627-003_8c84155d-4436-404a-bb05-aee683889f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Interferon Beta-1a
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Biogen Inc.
Application
BLA103628
Marketing category
BLA
Marketing start
2003-05-23
Substance
INTERFERON BETA-1A
Active strength
30 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
Avonex Pen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INTERFERON BETA-1A30 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XRO4566Q4RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727813Internal RxNorm lookup
727816Internal RxNorm lookup
797544Internal RxNorm lookup
1650899Internal RxNorm lookup
1650901Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d70a39cc-de15-4c12-a1ec-8063b69ea0e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
326327f0-4d6d-4c84-bc6d-8d84a27e249fProduct name120191002
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
59627-003-01Avonex Pen0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.523
59627-003-01Avonex Pen1 in 1 CARTONINJECTION, SOLUTION123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59627-003-01ML - Milliliter59627-0030402b1c4-7d0d-4581-afc8-44414f5a5b4e12015-10-02
59627-003-04EA - Each59627-003ad8265dc-8158-4da9-b818-01e06c6e476b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
interferon beta-1aACTIVE INGREDIENTXRO4566Q4RAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302AVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
interferon beta-1aACTIVE MOIETYXRO4566Q4RAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302AVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
acetic acidINACTIVE INGREDIENTQ40Q9N063PAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
Arginine hydrochlorideINACTIVE INGREDIENTF7LTH1E20YAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
Sodium acetateINACTIVE INGREDIENT4550K0SC9BAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RAVONEX (INTERFERON BETA-1A) KIT [BIOGEN IDEC INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59627-003AVONEX (INTERFERON BETA-1A) KIT AVONEX PEN (INTERFERON BETA-1A) INJECTION, SOLUTION AVONEX (INTERFERON BETA-1A) INJECTION, SOLUTION [BIOGEN INC.]22Current NDC, Legacy NDC, 2 package rows20241115_d70a39cc-de15-4c12-a1ec-8063b69ea0e1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AvonexINTERFERON BETA-1ABiogen Inc.d70a39cc-de15-4c12-a1ec-8063b69ea0e12025-11-19Warnings, Adverse reactionsExact identifier
application number: BLA103628
ndc (product): 59627-003

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103628Avonexinterferon beta-1a351(a)Disc2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650901Avonex 30 MCG in 0.5 ML Auto-InjectorPSNd70a39cc-de15-4c12-a1ec-8063b69ea0e123
727816Avonex 30 MCG in 0.5 ML Prefilled SyringePSNd70a39cc-de15-4c12-a1ec-8063b69ea0e123
1650899interferon beta-1a 30 MCG in 0.5 ML Auto-InjectorPSNd70a39cc-de15-4c12-a1ec-8063b69ea0e123
727813interferon beta-1a 30 MCG in 0.5 ML Prefilled SyringePSNd70a39cc-de15-4c12-a1ec-8063b69ea0e123
797544isopropyl alcohol 70 % Medicated PadPSNd70a39cc-de15-4c12-a1ec-8063b69ea0e123
16509010.5 ML interferon beta-1a 0.06 MG/ML Auto-Injector [Avonex]SBDd70a39cc-de15-4c12-a1ec-8063b69ea0e123
7278160.5 ML interferon beta-1a 0.06 MG/ML Prefilled Syringe [Avonex]SBDd70a39cc-de15-4c12-a1ec-8063b69ea0e123
16508990.5 ML interferon beta-1a 0.06 MG/ML Auto-InjectorSCDd70a39cc-de15-4c12-a1ec-8063b69ea0e123
7278130.5 ML interferon beta-1a 0.06 MG/ML Prefilled SyringeSCDd70a39cc-de15-4c12-a1ec-8063b69ea0e123
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDd70a39cc-de15-4c12-a1ec-8063b69ea0e123
16509010.5 ML Avonex 0.06 MG/ML Auto-InjectorSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
727816Avonex 0.03 MG per 0.5 ML Prefilled SyringeSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
1650901Avonex 30 MCG per 0.5 ML Auto-InjectorSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
727816Avonex 30 MCG per 0.5 ML Prefilled SyringeSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
727813interferon beta-1a 0.03 MG per 0.5 ML Prefilled SyringeSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
1650899interferon beta-1a 30 MCG per 0.5 ML Auto-InjectorSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
727813interferon beta-1a 30 MCG per 0.5 ML Prefilled SyringeSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
797544isopropyl alcohol 70 % Medicated PadSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
797544isopropyl alcohol 70 % Topical ClothSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123
797544isopropyl alcohol 70 % Topical SwabSYd70a39cc-de15-4c12-a1ec-8063b69ea0e123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59627-003-01596270003011 SYRINGE in 1 CARTON (59627-003-01) / .5 mL in 1 SYRINGE1 syringe2003-05-230000-00-00NoNoCurrent
59627-003-04596270003044 BOX in 1 CARTON (59627-003-04) > 1 SYRINGE in 1 BOX (59627-003-01) > .5 mL in 1 SYRINGE4 box2003-05-230000-00-00NoNoCurrent