68982-182 NDC - WILATE - VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN) (VON WILLEBRAND FACTOR/COAGULATION FACTOR VIII COMPLEX (HUMAN))

Drug Information

Product NDC: 68982-182

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

Non Proprietary Name: von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Active Ingredient(s):
  • 100 [iU]/mL ANTIHEMOPHILIC FACTOR HUMAN;
  • 100 [iU]/mL VON WILLEBRAND FACTOR HUMAN


Administration Route(s): INTRAVENOUS

Dosage Form(s): POWDER, FOR SOLUTION

Pharmacy Class(es):
  • 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]

Labeler Information

Labeler Name: Octapharma USA Inc
Product Type: PLASMA DERIVATIVE
FDA Application Number: BLA125251
Marketing Category: BLA
Start Marketing Date:12/4/2009

Package Information

No. Package Code Package Description Billing Unit
168982-182-015 mL in 1 VIAL (68982-182-01)EA
268982-182-0210 mL in 1 VIAL (68982-182-02)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC68982-182The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEPLASMA DERIVATIVEIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEWilate - von Willebrand Factor/Coagulation Factor VIII Complex (Human)The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEvon Willebrand Factor/Coagulation Factor VIII Complex (Human)The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDER, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/4/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA125251This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEOctapharma USA IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANTIHEMOPHILIC FACTOR HUMAN; VON WILLEBRAND FACTOR HUMANAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH100; 100 
ACTIVE INGRED UNIT[iU]/mL; [iU]/mL 
PHARM CLASSESBlood 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] 

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This page was last updated on: 2/1/2023