Dialyvite Tablet, Coated
NDC 10542-010

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10542-010?
  5. Dialyvite Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Dialyvite (ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid) is a UNAPPROVED DRUG OTHER-approved product labeled by Hillestad Pharmaceuticals Usa. This product is a combination of B vitamins used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, alcoholism, or during pregnancy. It is supplied as a pink tablet, coated for oral administration. This product entry covers the primary NDC 10542-010 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
10542-010
Proprietary Name:
Dialyvite
Non-Proprietary Name: [1]
Ascorbic Acid, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Folic Acid, Cobalamin, Biotin, Pantothenic Acid
Substance Name: [2]
Ascorbic Acid; Biotin; Calcium Pantothenate; Cobalamin; Folic Acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Hillestad Pharmaceuticals Usa
Labeler Code:
10542
Product Label ID:
7a5e6dd6-5687-44bb-8964-841961c0e64a
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
08-01-1988
End Marketing Date: [10]
01-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
PINK (C48328)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
H
Score:
1

Code Structure Chart

Product Details

What is NDC 10542-010?

The NDC code 10542-010 is assigned by the FDA to the product Dialyvite. It is commonly known by its generic name, ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cobalamin, biotin, pantothenic acid. This pharmaceutical product is labeled by Hillestad Pharmaceuticals Usa and is currently categorized as listed product. The medication is a tablet, coated administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 10542-010-02, 10542-010-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This product is a combination of B vitamins used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, alcoholism, or during pregnancy. Vitamins are important building blocks of the body and help keep you in good health. B vitamins include thiamine, riboflavin, niacin/niacinamide, vitamin B6, vitamin B12, folic acid, and pantothenic acid. Some brands of B vitamins also contain ingredients such as vitamin C, vitamin E, biotin, or zinc. Consult your doctor or pharmacist if you have questions about the ingredients in your brand.

What are Active Ingredients of this product?

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 100 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 300 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.
  • CALCIUM PANTOTHENATE 10 mg/1 - A butyryl-beta-alanine that can also be viewed as pantoic acid complexed with BETA ALANINE. It is incorporated into COENZYME A and protects cells against peroxidative damage by increasing the level of GLUTATHIONE.
  • COBALAMIN 6 ug/1
  • FOLIC ACID 1 mg/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.
  • NIACINAMIDE 20 mg/1 - An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
  • PYRIDOXINE HYDROCHLORIDE 10 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).
  • RIBOFLAVIN 1.7 mg/1 - Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as FLAVIN MONONUCLEOTIDE and FLAVIN-ADENINE DINUCLEOTIDE.
  • THIAMINE MONONITRATE 1.5 mg/1 - 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 of this product?

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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Patient Education

Cholecalciferol (Vitamin D3)


Cholecalciferol (vitamin D3) is used as a dietary supplement when the amount of vitamin D in the diet is not enough. People most at risk for vitamin D deficiency are older adults, breastfed infants, people with dark skin, obese people, and those with limited sun exposure, or gastrointestinal disease (GI; affecting the stomach or intestines) such as Crohn's disease or celiac disease. Cholecalciferol (vitamin D3) is also used along with calcium to prevent and treat bone diseases such as rickets (softening and weakening of bones in children caused by lack of vitamin D), osteomalacia (softening and weakening of bones in adults caused by lack of vitamin D), and osteoporosis (a condition in which the bones become thin and weak and break easily). Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.
[Learn More]


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Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".