75854-313 NDC - PRENATE ESSENTIAL (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, 5-METHYLTETRAHYDROFOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENT)

Drug Information

  • Product NDC: 75854-313
  • Proprietary Name: Prenate Essential
  • Non Proprietary Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapent
  • Active Ingredient(s): 10 [iU]/1 .ALPHA.-TOCOPHEROL ACETATE, DL-; 600 ug/1 5-METHYLTETRAHYDROFOLIC ACID; 90 mg/1 ASCORBIC ACID; 280 ug/1 BIOTIN; 155 mg/1 CALCIUM FORMATE; 220 [iU]/1 CHOLECALCIFEROL; 13 ug/1 CYANOCOBALAMIN; 300 mg/1 DOCONEXENT; 18 mg/1 FERROUS ASPARTO GLYCINATE; 400 ug/1 FOLIC ACID; 40 mg/1 ICOSAPENT; 50 mg/1 MAGNESIUM OXIDE; 150 ug/1 POTASSIUM IODIDE; 26 mg/1 PYRIDOXINE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE, GELATIN COATED
  • Pharmacy Class(es): Analogs/Derivatives [Chemical/Ingredient]; 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 B 12 [CS]; Vitamin B 6 [Chemical/Ingredient]; Vitamin B12 [EPC]; Vitamin B6 Analog [EPC]; Vitamin C [EPC]; Vitamin D [CS]; Vitamin D [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Avion Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:7/18/2014

Package Information

No. Package Code Package Description Billing Unit
175854-313-3030 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-313-30)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC75854-313The 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 NAMEPrenate EssentialThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, 5-methyltetrahydrofolic acid, cyanocobalamin, biotin, calcium formate, ferrous asparto glycinate, potassium iodide, magnesium oxide, doconexent and icosapentThe 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 DATE7/18/2014This 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 NAMEAvion Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME.ALPHA.-TOCOPHEROL ACETATE, DL-; 5-METHYLTETRAHYDROFOLIC ACID; ASCORBIC ACID; BIOTIN; CALCIUM FORMATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS ASPARTO GLYCINATE; FOLIC ACID; ICOSAPENT; MAGNESIUM OXIDE; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDEAn 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 STRENGTH10; 600; 90; 280; 155; 220; 13; 300; 18; 400; 40; 50; 150; 26 
ACTIVE INGRED UNIT[iU]/1; ug/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1 
PHARM CLASSESAnalogs/Derivatives [Chemical/Ingredient], 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 B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC] 

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This page was last updated on: 12/19/2025

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