63479-0403 NDC - D03 (BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, PHENOL, MILK THISTLE, CHELIDONIUM MAJUS, JUNIPER BERRY, LYCOPODIUM CLAVATUM SPORE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, LACTIC ACID, L-, TARAXACUM OFFICINALE, VISCUM ALBUM FRUITING TOP, AND YUCCA FILAMENTOSA)

Drug Information

Product NDC: 63479-0403
Proprietary Name: D03
Non Proprietary Name: berberis vulgaris root bark, bryonia alba root, phenol, milk thistle, chelidonium majus, juniper berry, lycopodium clavatum spore, sodium phosphate, dibasic, heptahydrate, sodium sulfate, strychnos nux-vomica seed, phosphorus, lactic acid, l-, taraxacum officinale, viscum album fruiting top, and yucca filamentosa
Active Ingredient(s): 1 [hp_X]/mL BERBERIS VULGARIS ROOT BARK; 12 [hp_X]/mL BRYONIA ALBA ROOT; 2 [hp_X]/mL CHELIDONIUM MAJUS; 1 [hp_X]/mL JUNIPER BERRY; 12 [hp_X]/mL LACTIC ACID, L-; 30 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE; 1 [hp_X]/mL MILK THISTLE; 12 [hp_X]/mL PHENOL; 12 [hp_X]/mL PHOSPHORUS; 15 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; 10 [hp_X]/mL SODIUM SULFATE; 30 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 12 [hp_X]/mL TARAXACUM OFFICINALE; 2 [hp_X]/mL VISCUM ALBUM FRUITING TOP; 1 [hp_X]/mL YUCCA FILAMENTOSA
Administration Route(s): SUBLINGUAL
Dosage Form(s): SOLUTION
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage 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	63479-0403-1	30 mL in 1 BOTTLE, GLASS (63479-0403-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63479-0403	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	D03	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	LVR-DRN	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	berberis vulgaris root bark, bryonia alba root, phenol, milk thistle, chelidonium majus, juniper berry, lycopodium clavatum spore, sodium phosphate, dibasic, heptahydrate, sodium sulfate, strychnos nux-vomica seed, phosphorus, lactic acid, l-, taraxacum officinale, viscum album fruiting top, and yucca filamentosa	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	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	BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; JUNIPER BERRY; LACTIC ACID, L-; LYCOPODIUM CLAVATUM SPORE; MILK THISTLE; PHENOL; PHOSPHORUS; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; VISCUM ALBUM FRUITING TOP; YUCCA FILAMENTOSA	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; 12; 2; 1; 12; 30; 1; 12; 12; 15; 10; 30; 12; 2; 1
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], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]

Drug Information

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Package Information

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