44911-0531 NDC - GUT BRAIN SPECTRUM (ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM)

Drug Information

Product NDC: 44911-0531
Proprietary Name: Gut Brain Spectrum
Non Proprietary Name: Abrotanum (Artemisia Abrotanum), Aethusa Cynapium, Baptisia Tinctoria, Cicuta Virosa, Cuprum Metallicum, Mezereum, Bufo Rana, Lac Materna Humanum, Saccharum Officinale, Serotonin (Hydrochloride), Alumina, Calcarea Phosphorica, Candida Albicans, Carcinosin, Helium, Lac Caninum, Mercurius solubilis, Natrum Muriaticum, Sulphur, Thuja Occidentalis, Formalinum, Morbillinum
Active Ingredient(s): 6 [hp_X]/mL AETHUSA CYNAPIUM WHOLE; 12 [hp_C]/mL ALUMINUM OXIDE; 6 [hp_X]/mL ARTEMISIA ABROTANUM FLOWERING TOP; 6 [hp_X]/mL BAPTISIA TINCTORIA ROOT; 15 [hp_X]/mL BUFO BUFO CUTANEOUS GLAND; 12 [hp_C]/mL CANDIDA ALBICANS; 12 [hp_C]/mL CANIS LUPUS FAMILIARIS MILK; 12 [hp_X]/mL CICUTA VIROSA ROOT; 12 [hp_X]/mL COPPER; 12 [hp_X]/mL DAPHNE MEZEREUM BARK; 15 [hp_C]/mL FORMALDEHYDE SOLUTION; 12 [hp_C]/mL HELIUM; 12 [hp_C]/mL HUMAN BREAST TUMOR CELL; 30 [hp_X]/mL HUMAN MILK; 15 [hp_C]/mL MEASLES VIRUS; 12 [hp_C]/mL MERCURIUS SOLUBILIS; 30 [hp_X]/mL SEROTONIN HYDROCHLORIDE; 12 [hp_C]/mL SODIUM CHLORIDE; 30 [hp_X]/mL SUCROSE; 12 [hp_C]/mL SULFUR; 12 [hp_C]/mL THUJA OCCIDENTALIS LEAFY TWIG; 12 [hp_C]/mL TRIBASIC CALCIUM PHOSPHATE
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Allergens [CS]; Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Cell-mediated Immunity [PE]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Fungal Proteins [CS]; Increased Coagulation Factor Activity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Inhibit Ovum Fertilization [PE]; Non-Standardized Fungal Allergenic Extract [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]

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:	3/5/2020
End Marketing Date:	11/8/2027

Package Information

No.	Package Code	Package Description	Billing Unit
1	44911-0531-1	30 mL in 1 BOTTLE, DROPPER (44911-0531-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	44911-0531	The 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 NAME	HUMAN OTC DRUG	Indicates 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 NAME	Gut Brain Spectrum	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Abrotanum (Artemisia Abrotanum), Aethusa Cynapium, Baptisia Tinctoria, Cicuta Virosa, Cuprum Metallicum, Mezereum, Bufo Rana, Lac Materna Humanum, Saccharum Officinale, Serotonin (Hydrochloride), Alumina, Calcarea Phosphorica, Candida Albicans, Carcinosin, Helium, Lac Caninum, Mercurius solubilis, Natrum Muriaticum, Sulphur, Thuja Occidentalis, Formalinum, Morbillinum	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/5/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	11/8/2027	This 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.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product 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 NAME	Energique, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	AETHUSA CYNAPIUM WHOLE; ALUMINUM OXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BUFO BUFO CUTANEOUS GLAND; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS MILK; CICUTA VIROSA ROOT; COPPER; DAPHNE MEZEREUM BARK; FORMALDEHYDE SOLUTION; HELIUM; HUMAN BREAST TUMOR CELL; HUMAN MILK; MEASLES VIRUS; MERCURIUS SOLUBILIS; SEROTONIN HYDROCHLORIDE; SODIUM CHLORIDE; SUCROSE; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TRIBASIC CALCIUM PHOSPHATE	An 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	6; 12; 6; 6; 15; 12; 12; 12; 12; 12; 15; 12; 12; 30; 15; 12; 30; 12; 30; 12; 12; 12
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
PHARM CLASSES	Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Fungal Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Fungal Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]

Drug Information

Labeler Information

Package Information

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