Drug Information

Product NDC: 54575-444

Proprietary Name: SWEET POTATO

Non Proprietary Name: sweet potato

Active Ingredient(s):
  • 1 g/20mL SWEET POTATO



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

Labeler Information

Labeler Name: Allergy Laboratories, Inc.
FDA Application Number: BLA102192
Marketing Category: BLA
Start Marketing Date:8/29/1972

Package Information

No. Package Code Package Description Billing Unit
154575-444-022 mL in 1 VIAL, MULTI-DOSE (54575-444-02)
254575-444-1010 mL in 1 VIAL, MULTI-DOSE (54575-444-10)
354575-444-3030 mL in 1 VIAL, MULTI-DOSE (54575-444-30)
454575-444-5050 mL in 1 VIAL, MULTI-DOSE (54575-444-50)

NDC Record

Field Name Field Value Definition
PRODUCT NDC54575-444The 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 NAMEHUMAN PRESCRIPTION DRUGIndicates 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 NAMESWEET POTATOThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEsweet potatoThe 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 NAMEPERCUTANEOUS; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/29/1972This 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 NUMBERBLA102192This 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 NAMEAllergy Laboratories, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESWEET POTATOThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESNon-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS] 

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