84858-1010 NDC - KUMARY (K-UMARY)

Drug Information

  • Product NDC: 84858-1010
  • Proprietary Name: kumary
  • Non Proprietary Name: k-umary
  • Active Ingredient(s): 30 mg/U ASCORBIC ACID; 40 mg/U CALCIUM CARBONATE; 70 mg/U CHONDROITIN SULFATE (BOVINE); 120 mg/U COLLAGEN ALPHA-2(I) CHAIN BOVINE; 120 mg/U HYALURONIC ACID; 50 mg/U HYDROLYZED SHEEP WOOL KERATIN (200 MW); 40 mg/U MAGNESIUM OXIDE; 10 mg/U MAGNESIUM STEARATE; 100 mg/U POVIDONE-IODINE; 120 mg/U TURMERIC
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Ascorbic Acid [CS]; Blood Coagulation Factor [EPC]; Calcium [CS]; Calculi Dissolution Agent [EPC]; Cations; Divalent [CS]; Increased Coagulation Factor Activity [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Vitamin C [EPC]

Labeler Information

Field Name Field Value
Labeler Name: METAZONKEY LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: M012
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:8/5/2024

Package Information

No. Package Code Package Description Billing Unit
184858-1010-130 U in 1 BOTTLE, PLASTIC (84858-1010-1)
284858-1010-230 U in 1 BOTTLE, PLASTIC (84858-1010-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC84858-1010The 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 NAMEkumaryThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEk-umaryThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE8/5/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct 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.
APPLICATION NUMBERM012This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMETAZONKEY LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEASCORBIC ACID; CALCIUM CARBONATE; CHONDROITIN SULFATE (BOVINE); COLLAGEN ALPHA-2(I) CHAIN BOVINE; HYALURONIC ACID; HYDROLYZED SHEEP WOOL KERATIN (200 MW); MAGNESIUM OXIDE; MAGNESIUM STEARATE; POVIDONE-IODINE; TURMERICAn 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 STRENGTH30; 40; 70; 120; 120; 50; 40; 10; 100; 120 
ACTIVE INGRED UNITmg/U; mg/U; mg/U; mg/U; mg/U; mg/U; mg/U; mg/U; mg/U; mg/U 
PHARM CLASSESAscorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin C [EPC] 

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This page was last updated on: 4/25/2025