65044-3696 NDC - FOOD - PLANT SOURCE, WALNUT, BLACK JUGLANS NIGRA (WALNUT, BLACK JUGLANS NIGRA)

Drug Information

Product NDC: 65044-3696

Proprietary Name: Food - Plant Source, Walnut, Black Juglans nigra

Non Proprietary Name: Walnut, Black Juglans nigra

Active Ingredient(s):
  • .1 g/mL BLACK WALNUT


Administration Route(s): PERCUTANEOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Non-Standardized Food Allergenic Extract [EPC];
  • Increased Histamine Release [PE];
  • Cell-mediated Immunity [PE];
  • Allergens [CS];
  • Dietary Proteins [CS];
  • Nut Proteins [EXT]

Labeler Information

Labeler Name: Jubilant HollisterStier LLC
Product Type: NON-STANDARDIZED ALLERGENIC
FDA Application Number: BLA103888
Marketing Category: BLA
Start Marketing Date:4/19/1941

Package Information

No. Package Code Package Description Billing Unit
165044-3696-15 mL in 1 VIAL (65044-3696-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC65044-3696The 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 NAMENON-STANDARDIZED 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 NAMEFood - Plant Source, Walnut, Black Juglans nigraThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEWalnut, Black Juglans nigraThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEPERCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/19/1941This 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 NUMBERBLA103888This 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 NAMEBLACK WALNUTThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.1 
ACTIVE INGRED UNITg/mL 
PHARM CLASSESNon-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 7/15/2019