63083-2039 NDC - KIDNEY STONE DROPS

Drug Information

Product NDC: 63083-2039
Proprietary Name: Kidney Stone Drops
Non Proprietary Name: Kidney Stone Drops
Active Ingredient(s): 6 [hp_X]/59mL BERBERIS VULGARIS ROOT BARK; 6 [hp_X]/59mL DIGITALIS; 2 [hp_X]/59mL EQUISETUM ARVENSE TOP; 6 [hp_X]/59mL HAWTHORN LEAF WITH FLOWER; 6 [hp_X]/59mL LYCOPODIUM CLAVATUM SPORE; 12 [hp_X]/59mL MERCURIC CHLORIDE; 6 [hp_X]/59mL NITRIC ACID; 30 [hp_X]/59mL OXALIC ACID; 6 [hp_X]/59mL POTASSIUM CARBONATE; 3 [hp_X]/59mL SMILAX ORNATA ROOT; 30 [hp_X]/59mL URIC ACID
Administration Route(s): ORAL
Dosage Form(s): LIQUID

Labeler Information

Field Name	Field Value
Labeler Name:	Professional Complementary Health Formulas
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	8/15/1984

Package Information

No.	Package Code	Package Description	Billing Unit
1	63083-2039-2	59 mL in 1 BOTTLE, DROPPER (63083-2039-2)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	63083-2039	The 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 NAME	HUMAN OTC DRUG	Indicates 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 NAME	Kidney Stone Drops	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX	2039	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAME	Kidney Stone Drops	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/15/1984	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product 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 NAME	Professional Complementary Health Formulas	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	BERBERIS VULGARIS ROOT BARK; DIGITALIS; EQUISETUM ARVENSE TOP; HAWTHORN LEAF WITH FLOWER; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; NITRIC ACID; OXALIC ACID; POTASSIUM CARBONATE; SMILAX ORNATA ROOT; URIC ACID	An 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 STRENGTH	6; 6; 2; 6; 6; 12; 6; 30; 6; 3; 30
ACTIVE INGRED UNIT	[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL

63083-2039 NDC - KIDNEY STONE DROPS

Drug Information

Labeler Information

Package Information

NDC Record

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