NDC 59088-187 Ventrixyl Fe

Ferrous Fumarate, Folic Acid

NDC Product Code 59088-187

NDC CODE: 59088-187

Proprietary Name: Ventrixyl Fe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ferrous Fumarate, Folic Acid 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Score: 1

NDC Code Structure

  • 59088 - Puretek Corporation

NDC 59088-187-54

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Ventrixyl Fe with NDC 59088-187 is a a human prescription drug product labeled by Puretek Corporation. The generic name of Ventrixyl Fe is ferrous fumarate, folic acid. The product's dosage form is tablet and is administered via oral form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug 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.

Ventrixyl Fe Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COCOA (UNII: D9108TZ9KG)
  • CROSPOVIDONE (UNII: 2S7830E561)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
  • Magnetic Resonance Contrast Activity - [MoA] (Mechanism of Action)
  • Paramagnetic Contrast Agent - [EPC] (Established Pharmacologic Class)
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Vitamin D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)
  • Vitamin A - [CS]
  • Vitamin A - [EPC] (Established Pharmacologic Class)
  • Vitamin B6 Analog - [EPC] (Established Pharmacologic Class)
  • Vitamin B 6 - [Chemical/Ingredient]
  • Analogs/Derivatives - [Chemical/Ingredient]
  • Vitamin B 12 - [CS]
  • Vitamin B12 - [EPC] (Established Pharmacologic Class)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Puretek Corporation
Labeler Code: 59088
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 08-11-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Ventrixyl Fe Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

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 (30 IU)

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

Iron (as ferrous fumarate)………………………………… 27 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
Other Ingredients:
Organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Clear coating: (hydroxypropyl methylcellulose, PEG-8).

Indications And Usage:

Ventrixyl™FE is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

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.

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.
Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B
12 is deficient.

Precautions:

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 B12 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 www.fda.gov/medwatch.

Drug Interactions:

Ventrixyl
TM FE
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).

Adverse Reactions:

Folic Acid: Allergic sensitizations have 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
Ventrixyl
™ FE
after meals may control occasional gastrointestinal disturbances.
Ventrixyl
™ FE
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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

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.
Ventrixyl™ FE 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 should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

Dosage And Administration:

Adults (persons over 12 years of age) One (1)
Ventrixyl™ FE caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

How Supplied:

Ventrixyl™ FE are beige speckled, oblong, coated caplets, in bottles containing 30 caplets – NDC 59088-187-54. 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.

Storage And Handling

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
877-921-7873.

Ventrixyl™ Fe

Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free:
877-921-7873

* Please review the disclaimer below.