44911-0670 NDC - GLUTENSTAT (ALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTEN)

Drug Information

  • Product NDC: 44911-0670
  • Proprietary Name: Glutenstat
  • Non Proprietary Name: Alfalfa, Zingiber Officinale, Cinchona Officinalis, Hydrastis Canadensis, Barley (Grain), Carbo Vegetabilis, Glyphosate, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Oat (Grain), Pulsatilla (Vulgaris), Rye (Grain), Wheat (Grain), Gluten
  • Active Ingredient(s): 12 [hp_X]/mL ACTIVATED CHARCOAL; 12 [hp_X]/mL BARLEY; 6 [hp_X]/mL CINCHONA OFFICINALIS BARK; 4 [hp_X]/mL GINGER; 12 [hp_X]/mL GLYPHOSATE; 6 [hp_X]/mL GOLDENSEAL; 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 4 [hp_X]/mL MEDICAGO SATIVA WHOLE; 12 [hp_X]/mL OAT; 12 [hp_X]/mL PULSATILLA VULGARIS WHOLE; 12 [hp_X]/mL RYE; 12 [hp_X]/mL SODIUM CHLORIDE; 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 12 [hp_X]/mL WHEAT; 16 [hp_X]/mL WHEAT GLUTEN
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Dietary Proteins [CS]; Dietary Proteins [CS]; Dietary Proteins [CS]; Dietary Proteins [CS]; Food Additives [CS]; Grain Proteins [EXT]; Grain Proteins [EXT]; Grain Proteins [EXT]; Grain Proteins [EXT]; Grain Proteins [EXT]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: Energique, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:4/5/2023

Package Information

No. Package Code Package Description Billing Unit
144911-0670-130 mL in 1 BOTTLE, DROPPER (44911-0670-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC44911-0670The 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 OTC 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 NAMEGlutenstatThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAlfalfa, Zingiber Officinale, Cinchona Officinalis, Hydrastis Canadensis, Barley (Grain), Carbo Vegetabilis, Glyphosate, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Oat (Grain), Pulsatilla (Vulgaris), Rye (Grain), Wheat (Grain), GlutenThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/5/2023This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMEEnergique, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACTIVATED CHARCOAL; BARLEY; CINCHONA OFFICINALIS BARK; GINGER; GLYPHOSATE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MEDICAGO SATIVA WHOLE; OAT; PULSATILLA VULGARIS WHOLE; RYE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; WHEAT; WHEAT GLUTENAn 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 STRENGTH12; 12; 6; 4; 12; 6; 12; 4; 12; 12; 12; 12; 12; 12; 16 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 4/4/2025

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