FDA.reportPublic FDA data

ENBREL

Product NDC
58406-425
11-digit product format
584060425
Labeler code
58406
Product ID
58406-425_e4897db8-5f5d-4216-b8ac-dbada29e8709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etanercept
Dosage form
KIT
Labeler
Immunex Corporation
Application
BLA103795
Marketing category
BLA
Marketing start
2003-01-02
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
58406-424-01ENBREL1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mL25 mg in 1mL218
58406-425-34ENBREL4 in 1 CARTONKIT4218
58406-425-41ENBREL1 in 1 KITKIT1218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58406-425-34EA - Each58406-4253d0f753a-b49f-4237-a137-981415eee59e12012-07-24
58406-425-41EA - Each58406-42564f02147-c3ef-4cac-8c49-896631535cff12012-07-24

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
58406-425ENBREL (ETANERCEPT) KIT ENBREL (ETANERCEPT) SOLUTION [IMMUNEX CORPORATION]211Legacy NDC, 3 package rows20250305_a002b40c-097d-47a5-957f-7a7b1807af7f.zip

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
58406-424-01584060424011 mL in 1 VIAL1 mlHistorical
58406-425-34584060425344 KIT in 1 CARTON (58406-425-34) > 1 KIT in 1 KIT (58406-425-41) * 1 mL in 1 VIAL (58406-424-01) * 1 mL in 1 SYRINGE (58406-910-01) 4 kit2003-01-020000-00-00NoNoCurrent
58406-425-41584060425411 in 1 KITHistorical