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

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 Identifiers#

Field, Values table
FieldValues
UniiOP401G7OJC
Rxcui253014, 261105, 727757, 802652, 809158, 809159, 1653223, 1653225, 2182338, 2182340, 2392140, 2392142

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

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