59469-158 NDC - APO-ENTERIT (CITRULLUS COLOCYNTHIS FRUIT PULP, PODOPHYLLUM, VERATRUM ALBUM ROOT, ARTEMISIA ABROTANUM FLOWERING TOP, CYNARA SCOLYMUS WHOLE, AND POTENTILLA ANSERINA FLOWERING TOP)

Drug Information

Product NDC: 59469-158

Proprietary Name: apo-ENTERIT

Non Proprietary Name: Citrullus colocynthis Fruit Pulp, Podophyllum, Veratrum album Root, Artemisia abrotanum Flowering Top, Cynara scolymus Whole, and Potentilla anserina Flowering Top

Active Ingredient(s):
  • 760 mg/50mL ARTEMISIA ABROTANUM FLOWERING TOP;
  • 4 [hp_X]/50mL CITRULLUS COLOCYNTHIS FRUIT PULP;
  • 2137 mg/50mL CYNARA SCOLYMUS WHOLE;
  • 4 [hp_X]/50mL PODOPHYLLUM;
  • 1092 mg/50mL POTENTILLA ANSERINA FLOWERING TOP;
  • 4 [hp_X]/50mL VERATRUM ALBUM ROOT


Administration Route(s): ORAL

Dosage Form(s): SOLUTION/ DROPS

Labeler Information

Labeler Name: PEKANA Naturheilmittel GmbH
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:4/12/2008

Package Information

No. Package Code Package Description Billing Unit
159469-158-101 BOTTLE, GLASS in 1 BOX (59469-158-10) / 50 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC59469-158The 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 NAMEapo-ENTERITThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECitrullus colocynthis Fruit Pulp, Podophyllum, Veratrum album Root, Artemisia abrotanum Flowering Top, Cynara scolymus Whole, and Potentilla anserina Flowering TopThe 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 DATE4/12/2008This 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 NAMEARTEMISIA ABROTANUM FLOWERING TOP; CITRULLUS COLOCYNTHIS FRUIT PULP; CYNARA SCOLYMUS WHOLE; PODOPHYLLUM; POTENTILLA ANSERINA FLOWERING TOP; VERATRUM ALBUM ROOTAn 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 STRENGTH760; 4; 2137; 4; 1092; 4 
ACTIVE INGRED UNITmg/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL; mg/50mL; [hp_X]/50mL 

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