Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Product NDC
67467-182
11-digit product format
674670182
Labeler code
67467
Product ID
67467-182_aae10ecc-a31e-d699-eff2-7540089705c4
Type
PLASMA DERIVATIVE
Nonproprietary name
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Application
BLA125251
Marketing category
BLA
Marketing start
2009-12-04
Marketing end
0000-00-00
Substance
ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN
Active strength
100 [iU]/mL; [iU]/mL
Pharmacologic classes
Human Antihemophilic Factor [EPC],Increased Coagulation Activity [PE],Blood Coagulation Factors [CS],Factor VIII [CS],Human Blood Coagulation Factor [EPC],Increased Platelet Aggregation [PE],Increased Coagulation Activity [PE],von Willebrand Factor [CS],Blood Coagulation Factors [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67467-182-01Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)5 mL in 1 VIALPOWDER, FOR SOLUTION512
67467-182-02Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)10 mL in 1 VIALPOWDER, FOR SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67467-182-01EA - Each67467-182471be033-24a5-43a3-96c1-695735786b8312012-07-24
67467-182-02EA - Each67467-1826d4af43a-0649-4d37-9798-99e77ebb8e5012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67467-182WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN) (VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]12Legacy NDC, 2 package rows20140317_d0379e0c-bb51-554e-a58b-b2afa60019d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661332antihemophilic factor / von Willebrand factor complex, human 1 UNT InjectionPSNd0379e0c-bb51-554e-a58b-b2afa60019d412
1661335wilate (expressed as von Willebrand factor) 1 UNT InjectionPSNd0379e0c-bb51-554e-a58b-b2afa60019d412
1661335factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Wilate]SBDd0379e0c-bb51-554e-a58b-b2afa60019d412
1661332factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT InjectionSCDd0379e0c-bb51-554e-a58b-b2afa60019d412
1661332factor VIII / von Willebrand Factor complex, human 1 UNT InjectionSYd0379e0c-bb51-554e-a58b-b2afa60019d412
1661335Wilate (expressed as von Willebrand factor) 1 UNT InjectionSYd0379e0c-bb51-554e-a58b-b2afa60019d412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67467-182-01674670182015 mL in 1 VIAL5 mlHistorical
67467-182-026746701820210 mL in 1 VIAL10 mlHistorical