Dexatran

Multivitamin

Puretek Corporation
Human Prescription Drug
NDC 59088-643

Dexatran also known as Multivitamin is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Dexatran is 59088-643. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Dexatran drug includes Calcium Pantothenate - 10 mg/1 Cupric Sulfate - .8 mg/1 Cyanocobalamin - 15 ug/1 Ferrous Fumarate - 18 mg/1 Folic Acid - 1 mg/1 Magnesium Sulfate Heptahydrate - 6.9 mg/1 Manganese Sulfate - 1.3 mg/1 Niacinamide - 30 mg/1 Pyridoxine Hydrochloride - 5 mg/1 Riboflavin - 6 mg/1 and more. The currest status of Dexatran drug is Active.

Drug Information:

Drug NDC:	59088-643
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Dexatran
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Multivitamin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Puretek Corporation
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CALCIUM PANTOTHENATE - 10 mg/1 CUPRIC SULFATE - .8 mg/1 CYANOCOBALAMIN - 15 ug/1 FERROUS FUMARATE - 18 mg/1 FOLIC ACID - 1 mg/1 MAGNESIUM SULFATE HEPTAHYDRATE - 6.9 mg/1 MANGANESE SULFATE - 1.3 mg/1 NIACINAMIDE - 30 mg/1 PYRIDOXINE HYDROCHLORIDE - 5 mg/1 RIBOFLAVIN - 6 mg/1 Load more... SODIUM ASCORBATE - 200 mg/1 THIAMINE MONONITRATE - 10 mg/1 ZINC SULFATE - 18.2 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	CUTANEOUS ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	15 Feb, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Jun, 2026
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.
Listing Expiration Date:	31 Dec, 2024
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	PureTek Corporation
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0359088643549
UPC stands for Universal Product Code.
NUI:	M0022794 N0000175951
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	568ET80C3D LRX7AJ16DT P6YC3EG204 R5L488RY0Q 935E97BOY8 SK47B8698T W00LYS4T26 25X51I8RD4 68Y4CF58BV TLM2976OFR Load more... S033EH8359 8K0I04919X 89DS0H96TB
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Vitamin B12 [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Vitamin B 12 [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Calculi Dissolution Agent [EPC] Copper Absorption Inhibitor [EPC] Decreased Copper Ion Absorption [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Magnetic Resonance Contrast Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B12 [EPC] Vitamin B6 Analog [EPC] Vitamin C [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
59088-643-54	30 CAPSULE in 1 BOTTLE, PLASTIC (59088-643-54)	15 Feb, 2023	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Dexatran

Multivitamin

Capsule
PureTek Corporation
NDC: 59088-643

Davimet

Multivitamin

Tablet, Chewable
PureTek Corporation
NDC: 59088-695

Product Elements:

Dexatran multivitamin silicon dioxide microcrystalline cellulose gellan gum (low acyl) hypromelloses water magnesium sulfate heptahydrate magnesium cation magnesium stearate riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid cyanocobalamin cyanocobalamin calcium pantothenate pantothenic acid sodium ascorbate ascorbic acid thiamine mononitrate thiamine ion thiamine zinc sulfate zinc cation manganese sulfate manganese cation (2+) ferrous fumarate ferrous cation cupric sulfate cupric cation light brown with specks

Indications and Usage:

Indications and usage: dexatranâ¢ is indicated to provide vitamin supplement 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.

Warnings:

Warnings: accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. keep this product out of reach of children. in case of accidental overdose, call a doctor or poison control center immediately. accidental of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin b 12 is deficient.

Dosage and Administration:

Dosage and administration: adults (persons over 12 years of age) one (1) dexatranâ¢ capsule daily, between meals or as directed by a physician. do not administer to children under the age of 12.

Contraindications:

Contraindications: this product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

Adverse Reactions:

Adverse reactions: folic acid: allergic sensitizations has been reported following both oral and parenteral administration of folic acid. ferrous fumarate: gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. although the absorption of iron is best when taken between meals, giving dexatranâ¢ after meals may control occasional gastrointestinal disturbances. dexatranâ¢ is best absorbed when taken at bedtime. 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.

Overdosage:

Overdose: iron: signs and symptoms: iron is toxic. acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. the estimated overdose of orally ingested iron is 300 mg/kg body weight. when overdoses are ingested by children, severe reactions, including fatalities, have resulted. dexatranâ¢ should be stored beyond the reach of children to prevent against accidental iron poisoning. keep this and all other drugs out of reach of children. treatment: for specific therapy, exchange transfusion and chelating agents shouldbe used. for general management, perform gastric lavage with sodium bicarbonate solution or milk. administer intravenous fluids and electrolytes and use oxygen.

Description:

Description: each capsule contains: vitamin c (as sodium ascorbate).................................200 mg thiamin (as thiamine mononitrate)............................... 10 mg riboflavin....................................................................... 6 mg niacin (as niacinamide)................................................ 30 mg vitamin b6 (as pyridoxine hydrochloride)....................... 5 mg folate (as folic acid)...... 1667 mcg dfe (1000 mcg folic acid) vitamin b12 (as cyanocobalamin).............................. 15 mcg pantothenic acid (as d-calcium pantothenate)............. 10 mg iron (as ferrous fumarate)............................................ 18 mg magnesium (as magnesium sulfate)............................ 6.9 mg zinc (as zinc sulfate).................................................. 18.2 mg copper (as cupric sulfate)........................................... 0.8 mg manganese (as manganese sulfate)............................ 1.3 mg other ingredients: magnesium stearate (vegetable source), microcrystalline cellulose, silicon dioxide, vegetable capsule.

How Supplied:

How supplied: dexatranâ¢ are transparent capsules in bottles containing 30 capsules â ndc 59088-643-54. dispense in a tight, light-resistant container as defined in the usp/nf with a child resistant closure. do not use if bottle seal is broken. keep this and all medications out of the reach of children. store at controlled room temperature 20o to 25oc (68o to 77of). [see usp]. protect from light and moisture and avoid excessive heat.

Package Label Principal Display Panel:

Dexatranâ¢ manufactured in the usa by: puretek corporation panorama city, ca 91402 questions? call toll-free: 1-877-921-7873 dexatran

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.