NDC 59088-193 Vitramyn
Folic Acid Tablet Oral
What is NDC 59088-193?
The NDC code 59088-193 is assigned by the FDA to the product Vitramyn which is a human prescription drug product labeled by Puretek Corporation. The generic name of Vitramyn is folic acid. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 59088-193-54 30 tablet in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Vitramyn?
Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
|Color(s)||YELLOW (C48330 - BEIGE SPECKLED, OBLONG, COATED CAPLETS) |
|Shape||CAPSULE (C48336) |
|Size(s)||19 MM |
NDC Code 59088-193-54
Package Description: 30 TABLET in 1 BOTTLE, PLASTIC
What are Vitramyn Active Ingredients?
- .ALPHA.-TOCOPHEROL ACETATE, DL- 30 mg/1
- ASCORBIC ACID 120 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.
- CALCIUM CARBONATE 200 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
- CHOLECALCIFEROL 20 ug/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.
- CHROMIUM NICOTINATE 35 ug/1
- CYANOCOBALAMIN 8 ug/1
- FOLIC ACID 1000 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.
- MAGNESIUM OXIDE 200 mg/1 - Magnesium oxide (MgO). An inorganic compound that occurs in nature as the mineral periclase. In aqueous media combines quickly with water to form magnesium hydroxide. It is used as an antacid and mild laxative and has many nonmedicinal uses.
- MANGANESE SULFATE 2.3 mg/1
- MOLYBDENUM 45 ug/1 - A metallic element with the atomic symbol Mo, atomic number 42, and atomic weight 95.95. It is an essential trace element, being a component of the enzymes xanthine oxidase, aldehyde oxidase, and nitrate reductase.
- 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 20 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 3.4 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.
- SELENIUM 55 ug/1 - An element with the atomic symbol Se, atomic number 34, and atomic weight 78.97. It is an essential micronutrient for mammals and other animals but is toxic in large amounts. Selenium protects intracellular structures against oxidative damage. It is an essential component of GLUTATHIONE PEROXIDASE.
- THIAMINE MONONITRATE 3 mg/1 - 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.
- VITAMIN A ACETATE 1500 ug/1
- ZINC OXIDE 25 mg/1 - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.
Vitramyn Active Ingredients UNII Codes
- SELENIUM (UNII: H6241UJ22B)
- SELENIUM (UNII: H6241UJ22B) (Active Moiety)
- CHOLECALCIFEROL (UNII: 1C6V77QF41)
- CHOLECALCIFEROL (UNII: 1C6V77QF41) (Active Moiety)
- RIBOFLAVIN (UNII: TLM2976OFR)
- RIBOFLAVIN (UNII: TLM2976OFR) (Active Moiety)
- NIACINAMIDE (UNII: 25X51I8RD4)
- NIACINAMIDE (UNII: 25X51I8RD4) (Active Moiety)
- ASCORBIC ACID (UNII: PQ6CK8PD0R)
- ASCORBIC ACID (UNII: PQ6CK8PD0R) (Active Moiety)
- FOLIC ACID (UNII: 935E97BOY8)
- FOLIC ACID (UNII: 935E97BOY8) (Active Moiety)
- CYANOCOBALAMIN (UNII: P6YC3EG204)
- CYANOCOBALAMIN (UNII: P6YC3EG204) (Active Moiety)
- CALCIUM CARBONATE (UNII: H0G9379FGK)
- CALCIUM CATION (UNII: 2M83C4R6ZB) (Active Moiety)
- VITAMIN A ACETATE (UNII: 3LE3D9D6OY)
- VITAMIN A (UNII: 81G40H8B0T) (Active Moiety)
- THIAMINE MONONITRATE (UNII: 8K0I04919X)
- THIAMINE ION (UNII: 4ABT0J945J) (Active Moiety)
- ZINC OXIDE (UNII: SOI2LOH54Z)
- ZINC CATION (UNII: 13S1S8SF37) (Active Moiety)
- MANGANESE SULFATE (UNII: W00LYS4T26)
- MANGANESE CATION (2+) (UNII: H6EP7W5457) (Active Moiety)
- .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
- .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (Active Moiety)
- MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
- MAGNESIUM CATION (UNII: T6V3LHY838) (Active Moiety)
- CHROMIUM NICOTINATE (UNII: A150AY412V)
- CHROMIC CATION (UNII: X1N4508KF1) (Active Moiety)
- PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
- PYRIDOXINE (UNII: KV2JZ1BI6Z) (Active Moiety)
- MOLYBDENUM (UNII: 81AH48963U)
- MOLYBDENUM (UNII: 81AH48963U) (Active Moiety)
Vitramyn Inactive Ingredients UNII Codes
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSES (UNII: 3NXW29V3WO)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- COCOA (UNII: D9108TZ9KG)
- CROSPOVIDONE (UNII: 2S7830E561)
- STEARIC ACID (UNII: 4ELV7Z65AP)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- Analogs/Derivatives - [Chemical/Ingredient]
- Ascorbic Acid - [CS]
- Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
- Calcium - [CS]
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Cations, Divalent - [CS]
- Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
- Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
- Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Paramagnetic Contrast Agent - [EPC] (Established Pharmacologic Class)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
- Vitamin A - [CS]
- Vitamin A - [EPC] (Established Pharmacologic Class)
- Vitamin B 12 - [CS]
- Vitamin B 6 - [Chemical/Ingredient]
- Vitamin B12 - [EPC] (Established Pharmacologic Class)
- Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
- Vitamin C - [EPC] (Established Pharmacologic Class)
- Vitamin D - [CS]
- Vitamin D - [EPC] (Established Pharmacologic Class)
* Please review the disclaimer below.
Vitramyn Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Each caplet contains:
Vitamin A (as retinyl acetate)……………….. 1500 mcg (5000 IU)
Vitamin C (as ascorbic acid)……………….……………… 120 mg
Vitamin D3 (as cholecalciferol)…………….……. 20 mcg (800 IU)
Vitamin E (dl-alpha tocopheryl acetate)……………. 30 mg (30IU)
Thiamin (as thiamine mononitrate)…………...……………… 3 mg
Riboflavin (vitamin B2)…………………………...…………. 3.4 mg
Niacin (as niacinamide)…………………………....………… 20 mg
Vitamin B6 (as pyridoxine hydrochloride)………….………. 20 mg
Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)
Vitamin B12 (as cyanocobalamin)………………….……….. 8 mcg
Calcium (as calcium carbonate)……………………...……. 200 mg
Magnesium (as magnesium oxide)……………………...… 200 mg
Zinc (as zinc oxide)………………………………………....... 25 mg
Selenium (as selenium amino acid chelate)……………….55 mcg
Manganese (as manganese sulfate)………………………. 2.3 mg
Chromium (as chromium polynicotinate)………………..... 35 mcg
Molybdenum (as molybdenum amino acid chelate)……... 45 mcg
Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).
Indications And Usage:
Vitramyn™ is indicated to provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or
Vitramyn™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel).
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
Dosage And Administration:
One (1) Vitramyn™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
Vitramyn™ are beige speckled, oblong, coated caplets in bottles containing 30 caplets – NDC 59088-193-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.
Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
Protect from light and moisture and avoid excessive heat.
To report a serious adverse event or to obtain product information, contact
Manufactured in the USA by:
Panorama City, CA 91402
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* Please review the disclaimer below.