53499-1166 NDC - UMCKA FASTACTIVES CHERRY (PELARGONIUM SIDOIDES)

Drug Information

Product NDC: 53499-1166

Proprietary Name: Umcka FastActives Cherry

Non Proprietary Name: Pelargonium sidoides

Active Ingredient(s):
  • 1 [hp_X]/700mg PELARGONIUM SIDOIDES ROOT


Administration Route(s): ORAL

Dosage Form(s): POWDER

Labeler Information

Labeler Name: Schwabe North America, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/3/2018

Package Information

No. Package Code Package Description Billing Unit
153499-1166-010 PACKET in 1 CARTON (53499-1166-0) / 700 mg in 1 PACKET

NDC Record

Field Name Field Value Definition
PRODUCT NDC53499-1166The 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 NAMEUmcka FastActives CherryThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPelargonium sidoidesThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDERThe 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 DATE7/3/2018This 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 NAMESchwabe North America, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPELARGONIUM SIDOIDES 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 STRENGTH1 
ACTIVE INGRED UNIT[hp_X]/700mg 

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