FDA.reportPublic FDA data

ELOCTATE

Product NDC
64406-801
11-digit product format
644060801
Labeler code
64406
Product ID
64406-801_d25b3c7e-cc02-4988-ace5-b238e42bd458
Type
PLASMA DERIVATIVE
Nonproprietary name
Antihemophilic Factor (Recombinant), Fc Fusion Protein
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Biogen Inc.
Application
BLA125487
Marketing category
BLA
Marketing start
2014-07-14
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64406-801DDiscontinued by firm2026-07-31
excluded packagepackage64406-80164406-801-01DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64406-801-012020-06-02C16284748780-19d75b9d0-c865-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ELOCTATE ® safely and effectively. See full prescribing information for ELOCTATE. ELOCTATE ® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2014
64406-801-012020-01-31C16284748780-19d75b9d0-c865-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ELOCTATE ® safely and effectively. See full prescribing information for ELOCTATE. ELOCTATE ® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-801-01EA - Each64406-8017f59e493-8bfc-4752-a155-57719ec20fdc12014-08-01

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125487EloctateAntihemophilic Factor (Recombinant), Fc Fusion protein351(a)Rx2026-06-01