FDA.reportPublic FDA data

NDC 58406-424-01 - ENBREL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58406-424
Requested NDC
58406-424-01
Package NDCs from labels
58406-424-01
Manufacturer
Immunex Corporation | Amgen Manufacturing Limited LLC
Effective date
2026-05-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ENBREL - Immunex Corporation | Amgen Manufacturing Limited LLCImmunex Corporation | Amgen Manufacturing Limited LLC2026-05-11HUMAN PRESCRIPTION DRUG LABEL

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58406-424ENBREL (ETANERCEPT) KIT ENBREL (ETANERCEPT) SOLUTION [IMMUNEX CORPORATION]211Unmatched20250305_a002b40c-097d-47a5-957f-7a7b1807af7f.zip

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 52 of 52 · 1,025 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.