Vitafol Capsule, Gelatin Coated
NDC 0642-0070

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0642-0070?
  5. Vitafol One Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Vitafol (prenatal supplement with dha) is a UNAPPROVED DRUG OTHER-approved product labeled by Exeltis Usa, Inc.. This medication is a multivitamin product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. It is supplied as a blue capsule, gelatin coated for oral administration. This product entry covers the primary NDC 0642-0070 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0642-0070
Proprietary Name:
Vitafol One
Non-Proprietary Name: [1]
Prenatal Supplement With Dha
Substance Name: [2]
.alpha.-tocopherol; Ascorbic Acid; Copper; Cyanocobalamin; Folic Acid; Iodine; Iron; Magnesium; Niacin; Omega-3 Fatty Acids; Pyridoxine Hydrochloride; Riboflavin; Thiamine Mononitrate; Vitamin A; Vitamin D; Zinc
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Exeltis Usa, Inc.
Labeler Code:
0642
Product Label ID:
42a5cafd-a2c0-4ac2-99c9-708642f00716
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]
06-13-2011
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333 - DARK BLUE)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
EV0070
Score:
1

Code Structure Chart

Product Details

What is NDC 0642-0070?

The NDC code 0642-0070 is assigned by the FDA to the product Vitafol One. It is commonly known by its generic name, prenatal supplement with dha. This pharmaceutical product is labeled by Exeltis Usa, Inc. and is currently categorized as listed product. The medication is a capsule, gelatin coated administered via oral route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 0642-0070-01, 0642-0070-03, 0642-0070-30. 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 medication is a multivitamin product used to treat or prevent vitamin deficiency due to poor diet, certain illnesses, or during pregnancy. Vitamins are important building blocks of the body and help keep you in good health.

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.
  • .ALPHA.-TOCOPHEROL 9 mg/1 - A natural tocopherol and one of the most potent antioxidant tocopherols. It exhibits antioxidant activity by virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus. It has four methyl groups on the 6-chromanol nucleus. The natural d form of alpha-tocopherol is more active than its synthetic dl-alpha-tocopherol racemic mixture.
  • 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.
  • COPPER 2 mg/1 - A heavy metal trace element with the atomic symbol Cu, atomic number 29, and atomic weight 63.55.
  • CYANOCOBALAMIN .012 mg/1
  • FOLIC ACID 1700 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.
  • IODINE .15 mg/1 - A nonmetallic element of the halogen group that is represented by the atomic symbol I, atomic number 53, and atomic weight of 126.90. It is a nutritionally essential element, especially important in thyroid hormone synthesis. In solution, it has anti-infective properties and is used topically.
  • IRON 29 mg/1 - A metallic element with atomic symbol Fe, atomic number 26, and atomic weight 55.85. It is an essential constituent of HEMOGLOBINS; CYTOCHROMES; and IRON-BINDING PROTEINS. It plays a role in cellular redox reactions and in the transport of OXYGEN.
  • MAGNESIUM 20 mg/1 - A metallic element that has the atomic symbol Mg, atomic number 12, and atomic weight 24.31. It is important for the activity of many enzymes, especially those involved in OXIDATIVE PHOSPHORYLATION.
  • NIACIN 15 mg/1 - A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.
  • OMEGA-3 FATTY ACIDS 200 mg/1 - A group of unsaturated fatty acids occurring mainly in fish oils, with three double bonds at particular positions in the hydrocarbon chain.
  • PYRIDOXINE HYDROCHLORIDE 2.5 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).
  • RIBOFLAVIN 1.8 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 1.6 mg/1 - 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.
  • VITAMIN A 330 ug/1 - Retinol and derivatives of retinol that play an essential role in metabolic functioning of the retina, the growth of and differentiation of epithelial tissue, the growth of bone, reproduction, and the immune response. Dietary vitamin A is derived from a variety of CAROTENOIDS found in plants. It is enriched in the liver, egg yolks, and the fat component of dairy products.
  • VITAMIN D 25 ug/1 - A vitamin that includes both CHOLECALCIFEROLS and ERGOCALCIFEROLS, which have the common effect of preventing or curing RICKETS in animals. It can also be viewed as a hormone since it can be formed in SKIN by action of ULTRAVIOLET RAYS upon the precursors, 7-dehydrocholesterol and ERGOSTEROL, and acts on VITAMIN D RECEPTORS to regulate CALCIUM in opposition to PARATHYROID HORMONE.
  • ZINC 25 mg/1 - A metallic element of atomic number 30 and atomic weight 65.38. It is a necessary trace element in the diet, forming an essential part of many enzymes, and playing an important role in protein synthesis and in cell division. Zinc deficiency is associated with ANEMIA, short stature, HYPOGONADISM, impaired WOUND HEALING, and geophagia. It is known by the symbol Zn.

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:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1119569 - ascorbic acid 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folic acid 1 MG / magnesium oxide 20 MG / niacin 15 MG / polysaccharide iron complex 29 MG / potassium iodide 0.15 MG / pyridoxine hydrochloride 2.5 MG / riboflavin 1.8 MG / thiamine mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / zinc oxide 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vitamin B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vitamin B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vitamin B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vit-B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vit-B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vitamin B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule
  • RxCUI: 1119569 - vitamin C 30 MG / cholecalciferol 1000 UNT / cuprous oxide 2 MG / folate 1 MG / magnesium oxide 20 MG / nicotinic acid 15 MG / polysaccharide iron complex 29 MG / K+ iodide 0.15 MG / vit-B6 hydrochloride 2.5 MG / riboflavin 1.8 MG / vit-B1 mononitrate 1.6 MG / vitamin A 1100 UNT / vitamin B12 0.012 MG / vitamin E 20 UNT / ZNO 25 MG Oral Capsule

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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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 Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
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".