44911-0539 NDC - SPLEENEX (ARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUM)

Drug Information

Product NDC: 44911-0539
Proprietary Name: Spleenex
Non Proprietary Name: Aralia Quinquefolia, Potassium Gluconate, Ginkgo Biloba, Magnesium Gluconicum Dihydricum, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malicum Acidum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Aconiticum Acidum, Cis-, Natrum Oxalaceticum
Active Ingredient(s): 12 [hp_X]/mL ACONITIC ACID, (Z)-; 3 [hp_X]/mL AMERICAN GINSENG; 8 [hp_X]/mL ANHYDROUS CITRIC ACID; 8 [hp_X]/mL COPPER; 8 [hp_X]/mL FUMARIC ACID; 8 [hp_X]/mL GERMANIUM SESQUIOXIDE; 6 [hp_X]/mL GINKGO; 6 [hp_X]/mL MAGNESIUM GLUCONATE; 8 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 8 [hp_X]/mL MALIC ACID; 9 [hp_X]/mL NAPHTHOQUINE; 8 [hp_X]/mL OXOGLURIC ACID; 3 [hp_X]/mL POTASSIUM GLUCONATE; 8 [hp_X]/mL PYRUVIC ACID; 12 [hp_X]/mL SODIUM DIETHYL OXALACETATE; 8 [hp_X]/mL SUCCINIC ACID; 6 [hp_X]/mL SUS SCROFA PANCREAS; 6 [hp_X]/mL SUS SCROFA SPLEEN; 6 [hp_X]/mL SUS SCROFA STOMACH; 8 [hp_X]/mL ZINC
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Acidifying Activity [MoA]; Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Calculi Dissolution Agent [EPC]; Calculi Dissolution Agent [EPC]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Coagulation Factor Activity [PE]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Increased Large Intestinal Motility [PE]; Inhibit Ovum Fertilization [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Osmotic Laxative [EPC]; Potassium Compounds [CS]; Potassium Salt [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

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:	3/19/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	44911-0539-1	30 mL in 1 BOTTLE, DROPPER (44911-0539-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	44911-0539	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	Spleenex	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX	V	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAME	Aralia Quinquefolia, Potassium Gluconate, Ginkgo Biloba, Magnesium Gluconicum Dihydricum, Pancreas Suis, Spleen (Suis), Stomach (Suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-Ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malicum Acidum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Aconiticum Acidum, Cis-, Natrum Oxalaceticum	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	3/19/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
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	ACONITIC ACID, (Z)-; AMERICAN GINSENG; ANHYDROUS CITRIC ACID; COPPER; FUMARIC ACID; GERMANIUM SESQUIOXIDE; GINKGO; MAGNESIUM GLUCONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALIC ACID; NAPHTHOQUINE; OXOGLURIC ACID; POTASSIUM GLUCONATE; PYRUVIC ACID; SODIUM DIETHYL OXALACETATE; SUCCINIC ACID; SUS SCROFA PANCREAS; SUS SCROFA SPLEEN; SUS SCROFA STOMACH; ZINC	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	12; 3; 8; 8; 8; 8; 6; 6; 8; 8; 9; 8; 3; 8; 12; 8; 6; 6; 6; 8
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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Coagulation Factor Activity [PE], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Drug Information

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