NDC 64406-486 - 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
64406-486
Package NDCs from labels
64406-486-08
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 38 of 55 · 1,086 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEAsclemed USA, Inc.f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff2024-05-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLC97001218-086c-430a-9e0d-6c7031c91d942024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCfe5b5182-c859-4c74-b2e0-467be5b2e3292024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.f2475fa3-ab1d-4b81-8127-b58cd0790a542024-05-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Weed Grass AntigensALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,Energique, Inc.8a28f56a-6010-42e3-b360-e6e22b86222a2024-05-02WarningsExact identifier
unii: 451W47IQ8X
Potassium Chloride in Sodium ChlorideSODIUM CHLORIDE AND POTASSIUM CHLORIDEFresenius Kabi USA, LLCc2467d57-cd2d-4409-bcc0-50128bd01bba2024-04-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Mineffect eye dropsALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltde2259f58-3043-4af3-918d-d4403757aa1f2024-04-26WarningsExact identifier
unii: 451W47IQ8X
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEFresenius Kabi USA, LLC7a723a23-3bc1-4f69-b82f-d06a35dc68d62024-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCc1e52670-c85e-4f19-a2e9-bf9abd7c37272024-04-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
DermaparEPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUMEnergique, Inc.f79fe29b-341e-4bee-9665-1805a7157d1a2024-04-22WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHikma Pharmaceuticals USA Inc.e5ee8caa-b6ca-45ba-98fb-8305e62821412024-04-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hers PlusCALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALISDeseret Biologicals,Inc.e4636b80-f6c8-459c-8d0e-ff7801358b102024-04-09WarningsExact identifier
unii: 451W47IQ8X
Dextrose And Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEB. Braun Medical Inc.8e6569ce-9714-497f-a94b-c6975c1d76f62024-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SINU HCPLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUMDeseret Biologicals, Inc.8b63e066-dd1b-4aee-a17b-4edc6b71a1cc2024-04-02WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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