FDA.reportPublic FDA data

ENBREL

Product NDC
50090-3531
Requested package NDC
50090-3531-0
11-digit product format
500903531
Labeler code
50090
Product ID
50090-3531_50bf9d27-2733-4e71-8393-94a0fc532692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etanercept
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA103795
Marketing category
BLA
Marketing start
2005-11-10
Marketing end
0000-00-00
Substance
ETANERCEPT
Active strength
50 mg/mL
Pharmacologic classes
Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-353150090-3531-0IInactivated by FDA2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENBRELETANERCEPTImmunex Corporationa002b40c-097d-47a5-957f-7a7b1807af7f2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103795

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0697f697-4635-4024-bcc8-bd30a9e66f12Product name120161228
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3531-02023-01-30C16284748780-19d75b9d0-0ad2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998
50090-3531-02021-03-01C16284748780-19d75b9d0-0ad2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998
50090-3531-02020-01-31C16284748780-19d75b9d0-0ad2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL ® (etanercept) injection, for subcutaneous use ENBREL ® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3531-0ENBREL1 mL in 1 KITSOLUTION111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3531ENBREL (ETANERCEPT) SOLUTION [A-S MEDICATION SOLUTIONS]11Legacy NDC, 1 package rows20210617_74bead6e-b746-4134-817f-0c053ef9e451.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103795Enbreletanercept351(a)Disc2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653225Enbrel 50 MG in 1 mL Auto-InjectorPSN74bead6e-b746-4134-817f-0c053ef9e45111
1653223etanercept 50 MG in 1 mL Auto-InjectorPSN74bead6e-b746-4134-817f-0c053ef9e45111
16532251 ML etanercept 50 MG/ML Auto-Injector [Enbrel]SBD74bead6e-b746-4134-817f-0c053ef9e45111
16532231 ML etanercept 50 MG/ML Auto-InjectorSCD74bead6e-b746-4134-817f-0c053ef9e45111
16532251 ML Enbrel 50 MG/ML Auto-InjectorSY74bead6e-b746-4134-817f-0c053ef9e45111
1653223etanercept 50 MG per 1 ML Auto-InjectorSY74bead6e-b746-4134-817f-0c053ef9e45111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3531-0500903531001 mL in 1 KIT (50090-3531-0) 1 ml2018-08-010000-00-00NoNoCurrent