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  4. NDC Product Code: 63044-631 Hematogen

NDC 63044-631 Hematogen

Ferrous Fumarate,Ascorbic Acid,Intrinsic Factor ,Cyanocobalamin Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63044-631?
  5. Hematogen Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
63044-631
Proprietary Name:
Hematogen
Non-Proprietary Name: [1]
Ferrous Fumarate, Ascorbic Acid, Intrinsic Factor , Cyanocobalamin
Substance Name: [2]
Ascorbic Acid; Cyanocobalamin; Ferrous Fumarate; Intrinsic Factor
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Nnodum Pharmaceuticals
    Labeler Code:
    63044
    Product Label ID:
    c36cb9d3-f0a3-4d34-92f2-8ab281b26b7d
    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]
    05-10-2007
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Shape:
    OVAL (C48345)
    Size(s):
    4 MM
    Imprint(s):
    ZIKS;631
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 63044-631?

    The NDC code 63044-631 is assigned by the FDA to the product Hematogen which is a human prescription drug product labeled by Nnodum Pharmaceuticals. The generic name of Hematogen is ferrous fumarate, ascorbic acid, intrinsic factor , cyanocobalamin. The product's dosage form is capsule and is administered via oral form. The product is distributed in a single package with assigned NDC code 63044-631-19 100 blister pack in 1 box / 1 capsule in 1 blister pack. 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 Hematogen?

    This medication is a multivitamin product used to treat or prevent low blood levels of iron and vitamin B12 (such as those caused by anemia or pregnancy). Iron is an important mineral that the body needs to produce red blood cells and keep you in good health. Vitamin B12 is important for growth, cell production, and nerve function. Vitamin C improves the absorption of iron from the stomach. Stomach concentrate (from pig stomachs) improves the absorption of vitamin B12.

    What are Hematogen 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.
    • ASCORBIC ACID 250 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.
    • CYANOCOBALAMIN 10 ug/1
    • FERROUS FUMARATE 66 mg/1
    • INTRINSIC FACTOR 100 mg/1 - A glycoprotein secreted by the cells of the GASTRIC GLANDS that is required for the absorption of VITAMIN B 12 (cyanocobalamin). Deficiency of intrinsic factor leads to VITAMIN B 12 DEFICIENCY and ANEMIA, PERNICIOUS.

    Which are Hematogen UNII Codes?

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

    Which are the Pharmacologic Classes for Hematogen?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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    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".