65044-3116 NDC - FOOD - PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO (CANTALOUPE CUCUMIS MELO)

Drug Information

  • Product NDC: 65044-3116
  • Proprietary Name: Food - Plant Source, Melon, Cantaloupe Cucumis melo
  • Non Proprietary Name: Cantaloupe Cucumis melo
  • Active Ingredient(s): .1 g/mL CANTALOUPE
  • Administration Route(s): PERCUTANEOUS; SUBCUTANEOUS
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Fruit Proteins [EXT]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
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
165044-3116-210 mL in 1 VIAL (65044-3116-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC65044-3116 
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, Melon, Cantaloupe Cucumis meloThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECantaloupe Cucumis meloThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
ROUTE NAMEPERCUTANEOUS; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/19/1941This 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.
MARKETING CATEGORY NAMEBLAName of Company corresponding to the labeler code segment of the Product NDC.
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 NAMECANTALOUPEAn 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 STRENGTH.1 
ACTIVE INGRED UNITg/mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC] 

Download Record

Download this NDC record record in Text format: Export

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

Download this NDC record record in XML format: Export

This page was last updated on: 12/6/2025

Previous Code
Next Code