65044-9941 NDC - WHITE FACED HORNET HYMENOPTERA VENOM MULTIDOSE

Drug Information

Product NDC: 65044-9941

Proprietary Name: White Faced Hornet Hymenoptera Venom Multidose

Non Proprietary Name: White Faced Hornet Hymenoptera Venom Multidose

Active Ingredient(s):
  • 100 ug/mL DOLICHOVESPULA MACULATA VENOM PROTEIN


Administration Route(s): PERCUTANEOUS; SUBCUTANEOUS

Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Standardized Insect Venom Allergenic Extract [EPC];
  • Wasp Venoms [CS]

Labeler Information

Labeler Name: Jubilant HollisterStier LLC
Product Type: STANDARDIZED ALLERGENIC
FDA Application Number: BLA103885
Marketing Category: BLA
Start Marketing Date:10/16/1979

Package Information

No. Package Code Package Description Billing Unit
165044-9941-55.5 mL in 1 VIAL (65044-9941-5)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC65044-9941The 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 NAMESTANDARDIZED ALLERGENICIndicates 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 NAMEWhite Faced Hornet Hymenoptera Venom MultidoseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEWhite Faced Hornet Hymenoptera Venom MultidoseThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEPERCUTANEOUS; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/16/1979This 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 NUMBERBLA103885This 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 NAMEJubilant HollisterStier LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDOLICHOVESPULA MACULATA VENOM PROTEINAn 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 
ACTIVE INGRED UNITug/mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC], Wasp Venoms [CS] 

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