FDA.reportPublic FDA data

ENBREL

Product NDC
58406-055
11-digit product format
584060055
Labeler code
58406
Product ID
58406-055_de3ee3bd-0047-4365-a4c7-5786521a1649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etanercept
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Immunex Corporation
Application
BLA103795
Marketing category
BLA
Marketing start
2020-03-05
Substance
ETANERCEPT
Active strength
25 mg/.5mL
Pharmacologic classes
Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
ndc (product): 58406-055

Additional Listing Data#

Finished product
Yes
Brand name base
ENBREL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETANERCEPT25 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OP401G7OJCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
253014Internal RxNorm lookup
261105Internal RxNorm lookup
727757Internal RxNorm lookup
802652Internal RxNorm lookup
809158Internal RxNorm lookup
809159Internal RxNorm lookup
1653223Internal RxNorm lookup
1653225Internal RxNorm lookup
2182338Internal RxNorm lookup
2182340Internal RxNorm lookup
2392140Internal RxNorm lookup
2392142Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a002b40c-097d-47a5-957f-7a7b1807af7fAvailable on FDA.report

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
58406-055-01ENBREL0.5 mL in 1 VIAL, SINGLE-DOSESOLUTION0.5218
58406-055-04ENBREL4 in 1 CARTONSOLUTION4218
58406-055-90ENBREL1 in 1 CARTONSOLUTION1218
58406-055-90ENBREL0.5 mL in 1 VIAL, SINGLE-DOSESOLUTION0.5218
58406-055-96ENBREL1 in 1 CARTONSOLUTION1218
58406-055-96ENBREL0.5 mL in 1 VIAL, SINGLE-DOSESOLUTION0.5218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58406-055-01ML - Milliliter58406-0552bf83255-5c1b-41c2-ad31-9b008a0436bc12025-05-14
58406-055-04ML - Milliliter58406-0558e2f11c4-3b2b-4b1a-a1f5-2c131a8a212f12020-09-14

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
58406-055ENBREL (ETANERCEPT) KIT ENBREL (ETANERCEPT) SOLUTION [IMMUNEX CORPORATION]211Current NDC, Legacy NDC, 6 package rows20250305_a002b40c-097d-47a5-957f-7a7b1807af7f.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
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
58406-055-01584060055010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
58406-055-04584060055044 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-04) / .5 mL in 1 VIAL, SINGLE-DOSE (58406-055-01) 2020-03-050000-00-00NoNoCurrent
58406-055-90584060055901 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-90) / .5 mL in 1 VIAL, SINGLE-DOSE2020-03-05YesNoCurrent
58406-055-96584060055961 VIAL, SINGLE-DOSE in 1 CARTON (58406-055-96) / .5 mL in 1 VIAL, SINGLE-DOSE2020-03-050000-00-00YesNoCurrent