FDA.reportPublic FDA data

NDC 64406-487 - ELOCTATE

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
64406-487
Package NDCs from labels
64406-487-08
Manufacturer
Biogen Inc.
Effective date
2020-08-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ELOCTATE - Biogen Inc.Biogen Inc.2020-08-04PLASMA DERIVATIVE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
(1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT)ACTIVE INGREDIENT7PCM518YLRELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2
(1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT)ACTIVE MOIETY7PCM518YLRELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2
HistidineINACTIVE INGREDIENT4QD397987EELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2
sucroseINACTIVE INGREDIENTC151H8M554ELOCTATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]2

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 8 of 55 · 1,086 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8dcbd-9e6b-1edc-e063-6394a90aac732026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBM Private Limited4d285396-9df8-86bc-e063-6294a90ad4de2026-03-16WarningsExact identifier
unii: 451W47IQ8X
HZ HPLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, RHUS TOX, SEPIA, THUJA OCCIDENTALISBioActive Nutritional, Inc.b662dea8-4eb5-4c80-a5ab-7d36887327732026-03-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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