FDA.reportPublic FDA data

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

Product NDC
68982-182
11-digit product format
689820182
Labeler code
68982
Product ID
68982-182_4a2195d5-2603-22a3-4a23-9e31111bde62
Type
PLASMA DERIVATIVE
Nonproprietary name
von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma USA Inc
Application
BLA125251
Marketing category
BLA
Marketing start
2009-12-04
Substance
ANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMAN
Active strength
100; 100 [iU]/mL; [iU]/mL
Pharmacologic classes
Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Factor VIII [CS], Human Antihemophilic Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Platelet Aggregation [PE], von Willebrand Factor [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIHEMOPHILIC FACTOR HUMAN100 [iU]/mL
VON WILLEBRAND FACTOR HUMAN100 [iU]/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-182-01Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)5 mL in 1 VIALPOWDER, FOR SOLUTION523
68982-182-02Wilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)10 mL in 1 VIALPOWDER, FOR SOLUTION1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-182-01EA - Each68982-1828b55ff1a-1b59-4416-8254-985e6bb73d7f12016-05-16
68982-182-02EA - Each68982-1823bc5d786-4c20-411c-b307-c10064a9514012016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-182WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN) (VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA USA INC]23Current NDC, Legacy NDC, 2 package rows20241128_a8ef06b8-b041-054e-e58d-fd8a994a8071.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661332antihemophilic factor / von Willebrand factor complex, human 1 UNT InjectionPSNa8ef06b8-b041-054e-e58d-fd8a994a807123
1661335wilate (expressed as von Willebrand factor) 1 UNT InjectionPSNa8ef06b8-b041-054e-e58d-fd8a994a807123
1661335factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Wilate]SBDa8ef06b8-b041-054e-e58d-fd8a994a807123
1661332factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT InjectionSCDa8ef06b8-b041-054e-e58d-fd8a994a807123
1661332factor VIII / von Willebrand Factor complex, human 1 UNT InjectionSYa8ef06b8-b041-054e-e58d-fd8a994a807123
1661335Wilate (expressed as von Willebrand factor) 1 UNT InjectionSYa8ef06b8-b041-054e-e58d-fd8a994a807123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-182-01689820182015 mL in 1 VIAL (68982-182-01) 5 ml2009-12-040000-00-00NoNoCurrent
68982-182-026898201820210 mL in 1 VIAL (68982-182-02) 10 ml2009-12-040000-00-00NoNoCurrent