NDC 59088-447 Foltrexyl

Folic Acid, Vitamin D3

NDC Product Code 59088-447

NDC CODE: 59088-447

Proprietary Name: Foltrexyl 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: Folic Acid, Vitamin D3 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • 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.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
8 MM
Score: 2

NDC Code Structure

  • 59088 - Puretek Corporation

NDC 59088-447-54

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Foltrexyl with NDC 59088-447 is a a human prescription drug product labeled by Puretek Corporation. The generic name of Foltrexyl is folic acid, vitamin d3. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Puretek Corporation

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.

Foltrexyl 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.

  • FOLIC ACID 1 mg/1
  • VITAMIN D 125 ug/1

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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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.
  • 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 D - [CS]
  • Vitamin D - [EPC] (Established Pharmacologic Class)

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: 10-29-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Foltrexyl Product Label Images

Foltrexyl 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

Foltrexyl™ is an orally administered prescription folate product for the dietary management of patients with unique

nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.

Foltrexyl™ should be administered under the supervision of

a licensed medical practitioner.

Each tablet contains:

Folate (as folic acid)……………………..1700 mcg DFE†

(1000 mcg folic acid)

Vitamin D3 (cholecalciferol)………....125 mcg (5000 IU)

Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium

starch glycolate, stearic acid, magnesium stearate.
† Dietary Folate Equivalent

Indications And Dosage

Foltrexyl™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate

levels and Vitamin D supplementation.
Foltrexyl™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.

Clinical Pharmacology

The
in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.
There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Foltrexyl™ is

contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Warnings And Precautions

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.

Dosage And Administration

Take one tablet daily or as directed by a healthcare practitioner.

How Supplied

Foltrexyl™ Tablets are supplied as round, light yellow tablets with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-447-54*).* This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2, 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Storage

KEEP OUT OF THE REACH OF CHILDREN.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Protect from heat, light and moisture.Tamper Evident: Do not use if seal is broken or missing
Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

* Please review the disclaimer below.