FDA.reportPublic FDA data

ENBREL

Product NDC
50090-4590
11-digit product format
500904590
Labeler code
50090
Product ID
50090-4590_3481a98e-52ad-4367-8a5d-fa3a7416ebf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etanercept
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA103795
Marketing category
BLA
Marketing start
2019-06-07
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4590DDiscontinued by firm2026-07-31
excluded packagepackage50090-459050090-4590-0DDiscontinued 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4590-02024-07-16C16284748780-1f386c649-99cc-0266-e053-dadaa90a7c1aThese 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
50090-4590-02023-01-30C16284748780-1f386c649-99cc-0266-e053-dadaa90a7c1aThese 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4590-0ML - Milliliter50090-4590eff7e080-bb70-457b-95d6-69176e9eb69412022-12-07

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
50090-4590-0500904590001 mL in 1 KIT (50090-4590-0) 1 ml2019-10-080000-00-00NoNoCurrent