FDA.reportPublic FDA data

ENBREL

Product NDC
58406-445
Requested package NDC
58406-445-04
11-digit product format
584060445
Labeler code
58406
Product ID
58406-445_e4897db8-5f5d-4216-b8ac-dbada29e8709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etanercept
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Immunex Corporation
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
2023-12-31
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 packagepackage58406-44558406-445-04DDiscontinued by firm2026-07-31

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58406-445-01ML - Milliliter58406-44520f52682-1d9b-426a-b550-e21c832998e412012-07-24
58406-445-04ML - Milliliter58406-445d46515e9-8d8b-4c75-8af0-628f051d08bb12012-07-24

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
802652Enbrel 50 MG in 1 mL Prefilled SyringePSN2dc2ed4b-f234-4ccc-bd95-0b63ac3ef4211
8026521 ML etanercept 50 MG/ML Prefilled Syringe [Enbrel]SBD2dc2ed4b-f234-4ccc-bd95-0b63ac3ef4211
7277571 ML etanercept 50 MG/ML Prefilled SyringeSCD2dc2ed4b-f234-4ccc-bd95-0b63ac3ef4211
8026521 ML Enbrel 50 MG/ML Prefilled SyringeSY2dc2ed4b-f234-4ccc-bd95-0b63ac3ef4211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58406-445-04584060445044 SYRINGE in 1 CARTON (58406-445-04) > 1 mL in 1 SYRINGE (58406-445-01) 4 syringe2005-11-100000-00-00NoNoCurrent