59469-112 NDC - ITIRES (BARIUM CARBONATE, CALCIUM IODIDE, HELIANTHEMUM CANADENSE, CONIUM MACULATUM FLOWERING TOP, SCROPHULARIA NODOSA, ECHINACEA, UNSPECIFIED, GALIUM APARINE, AND JUGLANS REGIA WHOLE)

Drug Information

Product NDC: 59469-112

Proprietary Name: ITIRES

Non Proprietary Name: Barium Carbonate, Calcium Iodide, Helianthemum canadense, Conium maculatum Flowering Top, Scrophularia nodosa, Echinacea, unspecified, Galium Aparine, and Juglans regia Whole

Active Ingredient(s):
  • 8 [hp_X]/50mL BARIUM CARBONATE;
  • 8 [hp_X]/50mL CALCIUM IODIDE;
  • 6 [hp_X]/50mL CONIUM MACULATUM FLOWERING TOP;
  • 12 [hp_X]/50mL ECHINACEA, UNSPECIFIED;
  • 6 [hp_X]/50mL GALIUM APARINE WHOLE;
  • 12 [hp_X]/50mL HELIANTHEMUM CANADENSE;
  • 6 [hp_X]/50mL JUGLANS REGIA WHOLE;
  • 4 [hp_X]/50mL SCROPHULARIA NODOSA WHOLE


Administration Route(s): ORAL

Dosage Form(s): SOLUTION/ DROPS

Pharmacy Class(es):
  • Blood Coagulation Factor [EPC];
  • Calcium [CS];
  • Cations;
  • Divalent [CS];
  • Increased Coagulation Factor Activity [PE]

Labeler Information

Labeler Name: PEKANA Naturheilmittel GmbH
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:12/11/2008

Package Information

No. Package Code Package Description Billing Unit
159469-112-101 BOTTLE, GLASS in 1 BOX (59469-112-10) / 50 mL in 1 BOTTLE, GLASS
259469-112-301 BOTTLE, GLASS in 1 BOX (59469-112-30) / 100 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-112The 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 NAMEITIRESThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBarium Carbonate, Calcium Iodide, Helianthemum canadense, Conium maculatum Flowering Top, Scrophularia nodosa, Echinacea, unspecified, Galium Aparine, and Juglans regia WholeThe 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 NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/11/2008This 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 NAMEPEKANA Naturheilmittel GmbHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBARIUM CARBONATE; CALCIUM IODIDE; CONIUM MACULATUM FLOWERING TOP; ECHINACEA, UNSPECIFIED; GALIUM APARINE WHOLE; HELIANTHEMUM CANADENSE; JUGLANS REGIA WHOLE; SCROPHULARIA NODOSA WHOLEAn 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 STRENGTH8; 8; 6; 12; 6; 12; 6; 4 
ACTIVE INGRED UNIT[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL 
PHARM CLASSESBlood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE] 

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This page was last updated on: 2/1/2023