63479-0401 NDC - D01 (ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE)

Drug Information

Product NDC: 63479-0401
Proprietary Name: D01
Non Proprietary Name: ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE
Active Ingredient(s): 1 [hp_X]/mL ALFALFA; 8 [hp_X]/mL ASPARAGUS; 15 [hp_X]/mL ATROPA BELLADONNA; 1 [hp_X]/mL AVENA SATIVA FLOWERING TOP; 6 [hp_X]/mL BERBERIS VULGARIS ROOT BARK; 10 [hp_X]/mL CHELIDONIUM MAJUS; 8 [hp_X]/mL GARLIC; 1 [hp_X]/mL GLYCYRRHIZA GLABRA; 12 [hp_X]/mL GOLDENSEAL; 6 [hp_X]/mL JUNIPERUS VIRGINIANA TWIG; 30 [hp_X]/mL LACTIC ACID, L-; 12 [hp_X]/mL NICKEL; 1 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP; 6 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP; 6 [hp_X]/mL TARAXACUM OFFICINALE
Administration Route(s): SUBLINGUAL
Dosage Form(s): SOLUTION/ DROPS
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; 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]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Standardized Chemical Allergen [EPC]; Vegetable Proteins [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Apex Energetics Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	3/15/1993

Package Information

No.	Package Code	Package Description	Billing Unit
1	63479-0401-1	30 mL in 1 BOTTLE, GLASS (63479-0401-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63479-0401	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	D01	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	DRAINAGE COMPLEX	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	ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE	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	SOLUTION/ DROPS	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	SUBLINGUAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/15/1993	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	Apex Energetics Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ALFALFA; ASPARAGUS; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; GARLIC; GLYCYRRHIZA GLABRA; GOLDENSEAL; JUNIPERUS VIRGINIANA TWIG; LACTIC ACID, L-; NICKEL; PASSIFLORA INCARNATA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE	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	1; 8; 15; 1; 6; 10; 8; 1; 12; 6; 30; 12; 1; 6; 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], Allergens [CS], Allergens [CS], 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], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]

Drug Information

Labeler Information

Package Information

NDC Record

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