FDA.reportPublic FDA data

ENBREL

Product NDC
58406-425
Requested package NDC
58406-425-34
11-digit product format
584060425
Labeler code
58406
Product ID
58406-425_e4897db8-5f5d-4216-b8ac-dbada29e8709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etanercept
Dosage form
KIT
Labeler
Immunex Corporation
Application
BLA103795
Marketing category
BLA
Marketing start
2003-01-02
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58406-42558406-425-34DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
0697f697-4635-4024-bcc8-bd30a9e66f12Product name120161228
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58406-424-01ENBREL1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mL25 mg in 1mL218
58406-425-34ENBREL4 in 1 CARTONKIT4218
58406-425-41ENBREL1 in 1 KITKIT1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58406-425-34EA - Each58406-4253d0f753a-b49f-4237-a137-981415eee59e12012-07-24
58406-425-41EA - Each58406-42564f02147-c3ef-4cac-8c49-896631535cff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETANERCEPTACTIVE INGREDIENTOP401G7OJCENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
ETANERCEPTACTIVE MOIETYOP401G7OJCENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20YENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
MANNITOLINACTIVE INGREDIENT3OWL53L36AENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
SUCROSEINACTIVE INGREDIENTC151H8M554ENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VENBREL (ETANERCEPT) SOLUTION ENBREL (ETANERCEPT) KIT [IMMUNEX CORPORATION]165

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58406-425ENBREL (ETANERCEPT) KIT ENBREL (ETANERCEPT) SOLUTION [IMMUNEX CORPORATION]211Legacy NDC, 3 package rows20250305_a002b40c-097d-47a5-957f-7a7b1807af7f.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
ENBRELETANERCEPTImmunex Corporationa002b40c-097d-47a5-957f-7a7b1807af7f2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103795
ndc (package): 58406-425-34
ndc (product): 58406-425
ndc11 (package): 58406042534

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103795Enbreletanercept351(a)Disc2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2392142Enbrel 25 MG in 0.5 mL InjectionPSNa002b40c-097d-47a5-957f-7a7b1807af7f218
809159Enbrel 25 MG in 0.5 mL Prefilled SyringePSNa002b40c-097d-47a5-957f-7a7b1807af7f218
261105Enbrel 25 MG/ML Injectable SolutionPSNa002b40c-097d-47a5-957f-7a7b1807af7f218
1653225Enbrel 50 MG in 1 mL Auto-InjectorPSNa002b40c-097d-47a5-957f-7a7b1807af7f218
2182340Enbrel 50 MG in 1 mL CartridgePSNa002b40c-097d-47a5-957f-7a7b1807af7f218
802652Enbrel 50 MG in 1 mL Prefilled SyringePSNa002b40c-097d-47a5-957f-7a7b1807af7f218
2392140etanercept 25 MG in 0.5 ML InjectionPSNa002b40c-097d-47a5-957f-7a7b1807af7f218
809158etanercept 25 MG in 0.5 mL Prefilled SyringePSNa002b40c-097d-47a5-957f-7a7b1807af7f218
253014etanercept 25 MG/ML Injectable SolutionPSNa002b40c-097d-47a5-957f-7a7b1807af7f218
1653223etanercept 50 MG in 1 mL Auto-InjectorPSNa002b40c-097d-47a5-957f-7a7b1807af7f218
2182338etanercept 50 MG in 1 mL CartridgePSNa002b40c-097d-47a5-957f-7a7b1807af7f218
23921420.5 ML etanercept 50 MG/ML Injection [Enbrel]SBDa002b40c-097d-47a5-957f-7a7b1807af7f218
8091590.5 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]SBDa002b40c-097d-47a5-957f-7a7b1807af7f218
16532251 ML etanercept 50 MG/ML Auto-Injector [Enbrel]SBDa002b40c-097d-47a5-957f-7a7b1807af7f218
21823401 ML etanercept 50 MG/ML Cartridge [Enbrel]SBDa002b40c-097d-47a5-957f-7a7b1807af7f218
8026521 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]SBDa002b40c-097d-47a5-957f-7a7b1807af7f218
261105etanercept 25 MG/ML Injectable Solution [Enbrel]SBDa002b40c-097d-47a5-957f-7a7b1807af7f218
23921400.5 ML etanercept 50 MG/ML InjectionSCDa002b40c-097d-47a5-957f-7a7b1807af7f218
8091580.5 ML etanercept 50 MG/ML Prefilled SyringeSCDa002b40c-097d-47a5-957f-7a7b1807af7f218
16532231 ML etanercept 50 MG/ML Auto-InjectorSCDa002b40c-097d-47a5-957f-7a7b1807af7f218
21823381 ML etanercept 50 MG/ML CartridgeSCDa002b40c-097d-47a5-957f-7a7b1807af7f218
7277571 ML etanercept 50 MG/ML Prefilled SyringeSCDa002b40c-097d-47a5-957f-7a7b1807af7f218
253014etanercept 25 MG/ML Injectable SolutionSCDa002b40c-097d-47a5-957f-7a7b1807af7f218
23921420.5 ML Enbrel 50 MG/ML InjectionSYa002b40c-097d-47a5-957f-7a7b1807af7f218
8091590.5 ML Enbrel 50 MG/ML Prefilled SyringeSYa002b40c-097d-47a5-957f-7a7b1807af7f218
16532251 ML Enbrel 50 MG/ML Auto-InjectorSYa002b40c-097d-47a5-957f-7a7b1807af7f218
21823401 ML Enbrel 50 MG/ML CartridgeSYa002b40c-097d-47a5-957f-7a7b1807af7f218
8026521 ML Enbrel 50 MG/ML Prefilled SyringeSYa002b40c-097d-47a5-957f-7a7b1807af7f218
2392142Enbrel 25 MG per 0.5 mL InjectionSYa002b40c-097d-47a5-957f-7a7b1807af7f218
261105Enbrel 25 MG/ML Injectable SolutionSYa002b40c-097d-47a5-957f-7a7b1807af7f218
2182340Enbrel 50 MG per 1 ML CartridgeSYa002b40c-097d-47a5-957f-7a7b1807af7f218
2392140etanercept 25 MG per 0.5 ML InjectionSYa002b40c-097d-47a5-957f-7a7b1807af7f218
809158etanercept 25 MG per 0.5 ML Prefilled SyringeSYa002b40c-097d-47a5-957f-7a7b1807af7f218
1653223etanercept 50 MG per 1 ML Auto-InjectorSYa002b40c-097d-47a5-957f-7a7b1807af7f218
2182338etanercept 50 MG per 1 ML CartridgeSYa002b40c-097d-47a5-957f-7a7b1807af7f218
809158etanercept 50 MG/ML per 0.5 ML Prefilled SyringeSYa002b40c-097d-47a5-957f-7a7b1807af7f218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58406-425-34584060425344 KIT in 1 CARTON (58406-425-34) > 1 KIT in 1 KIT (58406-425-41) * 1 mL in 1 VIAL (58406-424-01) * 1 mL in 1 SYRINGE (58406-910-01) 4 kit2003-01-020000-00-00NoNoCurrent