53645-1880 NDC - BRYONIA ALBA

Drug Information

Product NDC: 53645-1880

Proprietary Name: Bryonia Alba

Non Proprietary Name: Bryonia Alba

Active Ingredient(s):
  • 6 [hp_X]/23g BRYONIA ALBA ROOT

Administration Route(s): ORAL

Dosage Form(s): GLOBULE

Labeler Information

Labeler Name: True Botanica, LLC
Product Type: HUMAN OTC DRUG
FDA Application Number:
Start Marketing Date:12/9/2017

Package Information

No. Package Code Package Description Billing Unit
153645-1880-223 g in 1 BOTTLE (53645-1880-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC53645-1880The 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 NAMEBryonia AlbaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBryonia AlbaThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGLOBULEThe 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 DATE12/9/2017This 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 NAMETrue Botanica, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBRYONIA ALBA 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.

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This page was last updated on: 4/12/2024