63479-0508 NDC - E08 (BETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINE)

Drug Information

  • Product NDC: 63479-0508
  • Proprietary Name: E08
  • Non Proprietary Name: BETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINE
  • Active Ingredient(s): 12 [hp_X]/mL ANAMIRTA COCCULUS SEED; 6 [hp_X]/mL BETULA PENDULA LEAF; 4 [hp_C]/mL BOS TAURUS ADRENAL GLAND; 7 [hp_C]/mL BOS TAURUS HYPOTHALAMUS; 7 [hp_C]/mL BOS TAURUS PITUITARY GLAND; 12 [hp_X]/mL CALCIUM IODIDE; 15 [hp_X]/mL CANIS LUPUS FAMILIARIS MILK; 30 [hp_X]/mL CARPINUS BETULUS FLOWER; 12 [hp_X]/mL COLCHICUM AUTUMNALE BULB; 9 [hp_X]/mL ELEUTHERO; 6 [hp_X]/mL FRANGULA PURSHIANA BARK; 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT; 9 [hp_X]/mL JUNIPERUS COMMUNIS STEM; 30 [hp_X]/mL LACTIC ACID, L-; 30 [hp_X]/mL OLEA EUROPAEA FLOWER; 30 [hp_X]/mL ORNITHOGALUM UMBELLATUM FLOWERING TOP; 12 [hp_X]/mL PASSIFLORA INCARNATA TOP; 12 [hp_X]/mL PHOSPHORIC ACID; 12 [hp_X]/mL POTASSIUM CARBONATE; 30 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC; 8 [hp_X]/mL RIBES NIGRUM FLOWER BUD; 30 [hp_X]/mL SEPIA OFFICINALIS JUICE; 9 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP; 30 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED; 4 [hp_C]/mL SUS SCROFA PINEAL GLAND; 7 [hp_C]/mL TRYPTOPHAN; 7 [hp_C]/mL TYROSINE
  • Administration Route(s): SUBLINGUAL
  • Dosage Form(s): SOLUTION/ DROPS
  • Pharmacy Class(es): Allergens [CS]; Blood Coagulation Factor [EPC]; Calcium [CS]; Cations; Divalent [CS]; Cell-mediated Immunity [PE]; Increased Coagulation Factor Activity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Plant Proteins [CS]; Potassium Compounds [CS]; Potassium Salt [EPC]; 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:8/15/1988

Package Information

No. Package Code Package Description Billing Unit
163479-0508-130 mL in 1 BOTTLE, GLASS (63479-0508-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC63479-0508The 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 NAMEHUMAN OTC DRUGIndicates 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 NAMEE08The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXBIOCLOCK REGULATORA 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 NAMEBETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBLINGUALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/15/1988This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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 NAMEApex Energetics Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEANAMIRTA COCCULUS SEED; BETULA PENDULA LEAF; BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; CALCIUM IODIDE; CANIS LUPUS FAMILIARIS MILK; CARPINUS BETULUS FLOWER; COLCHICUM AUTUMNALE BULB; ELEUTHERO; FRANGULA PURSHIANA BARK; GELSEMIUM SEMPERVIRENS ROOT; JUNIPERUS COMMUNIS STEM; LACTIC ACID, L-; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA TOP; PHOSPHORIC ACID; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; RIBES NIGRUM FLOWER BUD; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; TYROSINEAn 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 STRENGTH12; 6; 4; 7; 7; 12; 15; 30; 12; 9; 6; 15; 9; 30; 30; 30; 12; 12; 12; 30; 8; 30; 9; 30; 4; 7; 7 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL 
PHARM CLASSESAllergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS] 

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This page was last updated on: 11/21/2025

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