FDA.reportPublic FDA data

ENBREL

Product NDC
58406-435
11-digit product format
584060435
Labeler code
58406
Product ID
58406-435_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
2005-10-06
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58406-435DDiscontinued by firm2026-07-31
excluded packagepackage58406-43558406-435-04DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58406-435-01ML - Milliliter58406-43539c8403a-79fd-4323-b6bf-d48311d735d512012-07-24
58406-435-04ML - Milliliter58406-435b3d8eafd-c2f5-4c74-a525-bb107fababf612012-07-24

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58406-435-04584060435044 SYRINGE in 1 CARTON (58406-435-04) > 1 mL in 1 SYRINGE (58406-435-01) 4 syringe2005-10-060000-00-00NoNoCurrent