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  4. NDC Product Code: 75854-316 Prenate Pixie

NDC 75854-316 Prenate Pixie

Ascorbic Acid,Biotin,Cholecalciferol,Cyanocobalamin,Folic Acid,Ferrous Asparto - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 75854-316?
  5. Prenate Pixie Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

NDC Product Code:
75854-316
Proprietary Name:
Prenate Pixie
Non-Proprietary Name: [1]
Ascorbic Acid, Biotin, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous Asparto Glycinate, Potassium Iodide, Pyridoxine Hydrochloride, .alpha.-tocopherol Acetate, Dl-, Docusate Sodium And Blueberry
Substance Name: [2]
.alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Biotin; Blueberry; Cholecalciferol; Cyanocobalamin; Docusate Sodium; Ferrous Asparto Glycinate; Folic Acid; Levomefolic Acid; Potassium Iodide; Pyridoxine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Avion Pharmaceuticals, Llc
    Labeler Code:
    75854
    Product Label ID:
    fe0a737e-4f28-40d8-b4a7-090edf86a823
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    08-15-2014
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    PURPLE (C48327)
    Shape:
    OVAL (C48345)
    Size(s):
    22 MM
    Imprint(s):
    PIX
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 75854-316?

    The NDC code 75854-316 is assigned by the FDA to the product Prenate Pixie which is a human prescription drug product labeled by Avion Pharmaceuticals, Llc. The generic name of Prenate Pixie is ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 75854-316-30 30 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Prenate Pixie?

    This medication is a multivitamin, mineral, and fatty acid product used to treat or prevent vitamin deficiency before, during, and after pregnancy. Vitamins, minerals, and fatty acids are important building blocks of the body and help keep you in good health. This combination product also contains iron and folic acid. Women of childbearing age should maintain adequate levels of folic acid either through diet or supplements to prevent infant spinal cord defects in the developing baby.

    What are Prenate Pixie Active Ingredients?

    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.
    • .ALPHA.-TOCOPHEROL ACETATE, DL- 10 [iU]/1
    • ASCORBIC ACID 30 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
    • BIOTIN 75 ug/1 - A water-soluble, enzyme co-factor present in minute amounts in every living cell. It occurs mainly bound to proteins or polypeptides and is abundant in liver, kidney, pancreas, yeast, and milk.
    • BLUEBERRY 5 mg/1 - Several species of the genus Vaccinium which produce the edible blueberry fruit.
    • CHOLECALCIFEROL 500 [iU]/1 - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
    • CYANOCOBALAMIN 13 ug/1
    • DOCUSATE SODIUM 200 mg/1 - All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.
    • FERROUS ASPARTO GLYCINATE 10 mg/1
    • FOLIC ACID 400 ug/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
    • LEVOMEFOLIC ACID 600 ug/1
    • POTASSIUM IODIDE 150 ug/1 - An inorganic compound that is used as a source of iodine in thyrotoxic crisis and in the preparation of thyrotoxic patients for thyroidectomy. (From Dorland, 27th ed)
    • PYRIDOXINE HYDROCHLORIDE 5 mg/1 - The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).

    Which are Prenate Pixie UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Prenate Pixie Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    Which are the Pharmacologic Classes for Prenate Pixie?

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - 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.

    [3] What kind of product is this? - 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".