44911-0257 NDC - LYMESTAT (CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, KALMIA LATIFOLIA, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, PHOSPHORUS, RHUS TOX)

Drug Information

Product NDC: 44911-0257

Proprietary Name: Lymestat

Non Proprietary Name: Chelidonium Majus, Echinacea, Hydrastis Canadensis, Arsenicum Album, Bryonia (Alba), Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus Tox

Active Ingredient(s):
  • 3 [hp_X]/mL CHELIDONIUM MAJUS;
  • 3 [hp_X]/mL ECHINACEA ANGUSTIFOLIA;
  • 3 [hp_X]/mL GOLDENSEAL;
  • 12 [hp_X]/mL ARSENIC TRIOXIDE;
  • 12 [hp_X]/mL BRYONIA ALBA ROOT;
  • 12 [hp_X]/mL COLCHICUM AUTUMNALE BULB;
  • 12 [hp_X]/mL KALMIA LATIFOLIA LEAF;
  • 12 [hp_X]/mL LEDUM PALUSTRE TWIG;
  • 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE;
  • 12 [hp_X]/mL PHOSPHORUS;
  • 12 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Energique, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:9/4/2015
End Marketing Date:10/2/2020

Package Information

No. Package Code Package Description Billing Unit
144911-0257-130 mL in 1 BOTTLE, DROPPER (44911-0257-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC44911-0257The 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 NAMELymestatThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEChelidonium Majus, Echinacea, Hydrastis Canadensis, Arsenicum Album, Bryonia (Alba), Colchicum Autumnale, Kalmia Latifolia, Ledum Palustre, Lycopodium Clavatum, Phosphorus, Rhus ToxThe 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 DATE9/4/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/2/2020This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NAMEEnergique, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECHELIDONIUM MAJUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAFThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH3; 3; 3; 12; 12; 12; 12; 12; 12; 12; 12 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 

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This page was last updated on: 9/13/2019