64578-0099 NDC - ENDOPATH-M (ADENOSINUM CYCLOPHOSPHORICUM, AGNUS CASTUS, ASPARAGUS OFFICINALIS, AVENA SATIVA, CADMIUM METALLICUM, DAMIANA, GLANDULA SUPRARENALIS SUIS, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, ORCHITINUM (BOVINE), PETROSELINUM SATIVUM, PITUITARUM POSTERIUM (BOVINE), PULSATILLA (VULGARIS), SABAL SERRULATA, SARSAPARILLA (SMILAX REGELII))

Drug Information

Product NDC: 64578-0099
Proprietary Name: Endopath-M
Non Proprietary Name: Adenosinum Cyclophosphoricum, Agnus Castus, Asparagus Officinalis, Avena Sativa, Cadmium Metallicum, Damiana, Glandula Suprarenalis Suis, Juniperus Communis, Lycopodium Clavatum, Orchitinum (Bovine), Petroselinum Sativum, Pituitarum Posterium (Bovine), Pulsatilla (Vulgaris), Sabal Serrulata, Sarsaparilla (Smilax Regelii)
Active Ingredient(s): 10 [hp_X]/mL ADENOSINE CYCLIC PHOSPHATE; 6 [hp_X]/mL ASPARAGUS; 4 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 9 [hp_X]/mL BOS TAURUS TESTICLE; 15 [hp_X]/mL CADMIUM; 4 [hp_X]/mL CHASTE TREE; 4 [hp_X]/mL JUNIPER BERRY; 4 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 4 [hp_X]/mL PETROSELINUM CRISPUM; 6 [hp_X]/mL PULSATILLA VULGARIS; 4 [hp_X]/mL SAW PALMETTO; 4 [hp_X]/mL SMILAX ORNATA ROOT; 9 [hp_X]/mL SUS SCROFA ADRENAL GLAND; 12 [hp_X]/mL SUS SCROFA PITUITARY GLAND; 6 [hp_X]/mL TURNERA DIFFUSA LEAFY TWIG
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Vegetable Proteins [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Energetix Corporation
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	10/8/2014

Package Information

No.	Package Code	Package Description	Billing Unit
1	64578-0099-1	59.1 mL in 1 BOTTLE, DROPPER (64578-0099-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	64578-0099	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	Endopath-M	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	Adenosinum Cyclophosphoricum, Agnus Castus, Asparagus Officinalis, Avena Sativa, Cadmium Metallicum, Damiana, Glandula Suprarenalis Suis, Juniperus Communis, Lycopodium Clavatum, Orchitinum (Bovine), Petroselinum Sativum, Pituitarum Posterium (Bovine), Pulsatilla (Vulgaris), Sabal Serrulata, Sarsaparilla (Smilax Regelii)	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	10/8/2014	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	Energetix Corporation	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ADENOSINE CYCLIC PHOSPHATE; ASPARAGUS; AVENA SATIVA FLOWERING TOP; BOS TAURUS TESTICLE; CADMIUM; CHASTE TREE; JUNIPER BERRY; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM; PULSATILLA VULGARIS; SAW PALMETTO; SMILAX ORNATA ROOT; SUS SCROFA ADRENAL GLAND; SUS SCROFA PITUITARY GLAND; TURNERA DIFFUSA LEAFY TWIG	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	10; 6; 4; 9; 15; 4; 4; 4; 4; 6; 4; 4; 9; 12; 6
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 CLASSES	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]

Drug Information

Labeler Information

Package Information

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