FDA.reportPublic FDA data

Avonex

Product NDC
59627-002
11-digit product format
596270002
Labeler code
59627
Product ID
59627-002_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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXRO4566Q4R
Rxcui727813, 727816, 797544, 1650899, 1650901

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
59627-002-06Avonex1 in 1 CARTONINJECTION, SOLUTION123
59627-002-07Avonex1 in 1 TRAYINJECTION, SOLUTION123
59627-002-07Avonex0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59627-002-05EA - Each59627-00231696ccb-f2fd-4e79-9d20-4172258cd41912012-07-24
59627-002-06ML - Milliliter59627-002a90c5f27-cfdb-465e-8b90-9c2a34c90f3e12021-09-07
59627-002-07ML - Milliliter59627-0025e7add05-1932-4c66-9876-ff82ad4af6a822015-10-02

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
59627-002AVONEX (INTERFERON BETA-1A) KIT AVONEX PEN (INTERFERON BETA-1A) INJECTION, SOLUTION AVONEX (INTERFERON BETA-1A) INJECTION, SOLUTION [BIOGEN INC.]22Current NDC, Legacy NDC, 3 package rows20241115_d70a39cc-de15-4c12-a1ec-8063b69ea0e1.zip

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
59627-002-05596270002054 TRAY in 1 CARTON (59627-002-05) > 1 SYRINGE in 1 TRAY (59627-002-07) > .5 mL in 1 SYRINGE4 tray2003-05-230000-00-00NoNoCurrent
59627-002-06596270002061 TRAY in 1 CARTON (59627-002-06) / 1 SYRINGE in 1 TRAY (59627-002-07) / .5 mL in 1 SYRINGE1 tray2003-05-230000-00-00NoNoCurrent
59627-002-07596270002071 in 1 TRAYHistorical