FDA.reportPublic FDA data

ALPROLIX

Product NDC
64406-977
11-digit product format
644060977
Labeler code
64406
Product ID
64406-977_39f5f856-b6e2-4aa3-bcdb-2cc97d2f948d
Type
PLASMA DERIVATIVE
Nonproprietary name
Coagulation Factor IX (Recombinant), Fc Fusion Protein
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Biogen Inc.
Application
BLA125444
Marketing category
BLA
Marketing start
2016-10-28
Marketing end
2020-10-31
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct64406-977DDiscontinued by firm2026-07-31
excluded packagepackage64406-97764406-977-01DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64406-977-012020-06-02C16284748780-19d75b9d1-063f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALPROLIX ® safely and effectively. see full prescribing information for ALPROLIX. ALPROLIX ® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection. Initial U.S. Approval: 2014
64406-977-012020-01-31C16284748780-19d75b9d1-063f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALPROLIX ® safely and effectively. see full prescribing information for ALPROLIX. ALPROLIX ® [Coagulation Factor IX (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
64406-977-01EA - Each64406-9778d79f641-7ce3-4a34-b810-47c48a8a2e2312016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Coagulation Factor IX Recombinant Immunoglubulin G1 Fusion ProteinACTIVE INGREDIENT02E00T2QDEALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]4
eftrenonacog alfaACTIVE MOIETY02E00T2QDEALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]4
histidineINACTIVE INGREDIENT4QD397987EALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]4
mannitolINACTIVE INGREDIENT3OWL53L36AALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]4
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]4
sucroseINACTIVE INGREDIENTC151H8M554ALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOGEN IDEC INC.]4

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125444AlprolixCoagulation Factor IX (Recombinant), Fc Fusion Protein351(a)Rx2026-06-01