64578-0149 NDC - KIDNEY-TONE (AGRIMONIA EUPATORIA, BERBERIS VULGARIS, CALCAREA OXALICA, CALCAREA PHOSPHORICA, CANTHARIS, ECHINACEA, EQUISETUM ARVENSE, FERRUM PHOSPHORICUM, LYCOPODIUM CLAVATUM, PAREIRA BRAVA, PETROSELINUM SATIVUM, RUBIA TINCTORUM, SARSAPARILLA, SOLIDAGO VIRGAUREA, UVA-URSI.)

Drug Information

  • Product NDC: 64578-0149
  • Proprietary Name: Kidney-Tone
  • Non Proprietary Name: Agrimonia eupatoria, Berberis vulgaris, Calcarea oxalica, Calcarea phosphorica, Cantharis, Echinacea, Equisetum arvense, Ferrum phosphoricum, Lycopodium clavatum, Pareira brava, Petroselinum sativum, Rubia tinctorum, Sarsaparilla, Solidago virgaurea, Uva-ursi.
  • Active Ingredient(s): 12 [hp_X]/59.1mL AGRIMONIA EUPATORIA; 5 [hp_X]/59.1mL ARCTOSTAPHYLOS UVA-URSI LEAF; 4 [hp_X]/59.1mL BERBERIS VULGARIS ROOT BARK; 12 [hp_X]/59.1mL CALCIUM OXALATE MONOHYDRATE; 4 [hp_X]/59.1mL CHONDRODENDRON TOMENTOSUM ROOT; 4 [hp_X]/59.1mL ECHINACEA, UNSPECIFIED; 12 [hp_X]/59.1mL EQUISETUM ARVENSE TOP; 12 [hp_X]/59.1mL FERROSOFERRIC PHOSPHATE; 12 [hp_X]/59.1mL LYCOPODIUM CLAVATUM SPORE; 12 [hp_X]/59.1mL LYTTA VESICATORIA; 4 [hp_X]/59.1mL PETROSELINUM CRISPUM; 12 [hp_X]/59.1mL RUBIA TINCTORUM ROOT; 5 [hp_X]/59.1mL SARSAPARILLA; 5 [hp_X]/59.1mL SOLIDAGO VIRGAUREA FLOWERING TOP; 12 [hp_X]/59.1mL TRIBASIC CALCIUM PHOSPHATE
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Blood Coagulation Factor [EPC]; Calcium [CS]; Calcium [CS]; Calcium [EPC]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]

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:4/1/2017

Package Information

No. Package Code Package Description Billing Unit
164578-0149-159.1 mL in 1 BOTTLE, DROPPER (64578-0149-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC64578-0149The 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 NAMEKidney-ToneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAgrimonia eupatoria, Berberis vulgaris, Calcarea oxalica, Calcarea phosphorica, Cantharis, Echinacea, Equisetum arvense, Ferrum phosphoricum, Lycopodium clavatum, Pareira brava, Petroselinum sativum, Rubia tinctorum, Sarsaparilla, Solidago virgaurea, Uva-ursi.The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/1/2017This 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 NAMEEnergetix CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAGRIMONIA EUPATORIA; ARCTOSTAPHYLOS UVA-URSI LEAF; BERBERIS VULGARIS ROOT BARK; CALCIUM OXALATE MONOHYDRATE; CHONDRODENDRON TOMENTOSUM ROOT; ECHINACEA, UNSPECIFIED; EQUISETUM ARVENSE TOP; FERROSOFERRIC PHOSPHATE; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; PETROSELINUM CRISPUM; RUBIA TINCTORUM ROOT; SARSAPARILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATEAn 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; 5; 4; 12; 4; 4; 12; 12; 12; 12; 4; 12; 5; 5; 12 
ACTIVE INGRED UNIT[hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL; [hp_X]/59.1mL 
PHARM CLASSESBlood Coagulation Factor [EPC], Calcium [CS], Calcium [CS], Calcium [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] 

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This page was last updated on: 5/9/2025

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