0037-6072 NDC - NATELLE ONE (DOCONEXENT, ICOSAPENT, CALCIUM, IRON, ASCORBIC ACID, PYRIDOXINE, .ALPHA.-TOCOPHEROL, FOLIC ACID)

Drug Information

Product NDC: 0037-6072

Proprietary Name: Natelle One

Non Proprietary Name: doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid

Active Ingredient(s):
  • 250 mg/1 DOCONEXENT;
  • .625 mg/1 ICOSAPENT;
  • 102 mg/1 CALCIUM;
  • 28 mg/1 IRON;
  • 30 mg/1 ASCORBIC ACID;
  • 25 mg/1 PYRIDOXINE;
  • 30 [iU]/1 .ALPHA.-TOCOPHEROL;
  • 1 mg/1 FOLIC ACID


Administration Route(s): ORAL

Dosage Form(s): CAPSULE, GELATIN COATED

Pharmacy Class(es):
  • Calcium [CS];
  • Calcium [EPC];
  • Phosphate Binder [EPC];
  • Phosphate Chelating Activity [MoA];
  • Vitamin C [EPC];
  • Ascorbic Acid [CS];
  • Vitamin B6 Analog [EPC];
  • Vitamin B 6 [Chemical/Ingredient];
  • Analogs/Derivatives [Chemical/Ingredient]

Labeler Information

Labeler Name: MEDA Pharmaceuticals
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/1/2015

Package Information

No. Package Code Package Description Billing Unit
10037-6072-3030 CAPSULE, GELATIN COATED in 1 BOTTLE (0037-6072-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0037-6072The 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 PRESCRIPTION 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 NAMENatelle OneThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdoconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acidThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, GELATIN COATEDThe 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 DATE2/1/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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 NAMEMEDA PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDOCONEXENT; ICOSAPENT; CALCIUM; IRON; ASCORBIC ACID; PYRIDOXINE; .ALPHA.-TOCOPHEROL; FOLIC ACIDThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH250; .625; 102; 28; 30; 25; 30; 1 
ACTIVE INGRED UNITmg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1 
PHARM CLASSESCalcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient] 

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This page was last updated on: 5/17/2019