85312-003 NDC - KIDNEY REPAIR CENTER (NIACIN L-ARGININE CITRULLINE MALATE ZINC CITRATE MACA ROOT EXTRACT OYSTER CONCENTRATED POWDERSELENIUM-RICH YEASTGINSENG EXTRACT)

Drug Information

Product NDC: 85312-003
Proprietary Name: Kidney Repair Center
Non Proprietary Name: Niacin L-arginine Citrulline malate Zinc citrate Maca root extract Oyster concentrated powderSelenium-rich yeastGinseng Extract
Active Ingredient(s): 10 mg/400mg ARGININE; 20 mg/400mg ASIAN GINSENG; 10 mg/400mg CITRULLINE MALATE; 18 mg/400mg NIACIN; 60 mg/400mg OCTYLDIMETHYLAMINE OXIDE; 30 mg/400mg PACIFIC OYSTER; 20 mg/400mg SELENOCYSTEINE; 20 mg/400mg ZINC CITRATE
Administration Route(s): ORAL
Dosage Form(s): GRANULE
Pharmacy Class(es): Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]; Nicotinic Acid [EPC]; Nicotinic Acids [CS]

Labeler Information

Field Name	Field Value
Labeler Name:	Panatural Life Science, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	3/9/2025

Package Information

No.	Package Code	Package Description	Billing Unit
1	85312-003-01	14 CAPSULE in 1 BOX (85312-003-01) / 400 mg in 1 CAPSULE

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	85312-003	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 Repair Center	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Niacin L-arginine Citrulline malate Zinc citrate Maca root extract Oyster concentrated powderSelenium-rich yeastGinseng Extract	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	GRANULE	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	3/9/2025	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	Panatural Life Science, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ARGININE; ASIAN GINSENG; CITRULLINE MALATE; NIACIN; OCTYLDIMETHYLAMINE OXIDE; PACIFIC OYSTER; SELENOCYSTEINE; ZINC CITRATE	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	10; 20; 10; 18; 60; 30; 20; 20
ACTIVE INGRED UNIT	mg/400mg; mg/400mg; mg/400mg; mg/400mg; mg/400mg; mg/400mg; mg/400mg; mg/400mg
PHARM CLASSES	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS]

85312-003 NDC - KIDNEY REPAIR CENTER (NIACIN L-ARGININE CITRULLINE MALATE ZINC CITRATE MACA ROOT EXTRACT OYSTER CONCENTRATED POWDERSELENIUM-RICH YEASTGINSENG EXTRACT)

Drug Information

Labeler Information

Package Information

NDC Record

Download Record