Folixapure
Folic Acid, Vitamin D3
Puretek Corporation
Human Prescription Drug
NDC 59088-163Folixapure also known as Folic Acid, Vitamin D3 is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Folixapure is 59088-163. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Folixapure drug includes Folic Acid - 1 mg/1 Vitamin D - 125 ug/1 . The currest status of Folixapure drug is Active.
Drug Information:
| Drug NDC: | 59088-163 |
| 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: | Folixapure |
| 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: | Folic Acid, Vitamin D3 |
| 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: | Tablet |
| 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: | FOLIC ACID - 1 mg/1
VITAMIN D - 125 ug/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | 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: | 10 Jul, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 Dec, 2025 |
| 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. |
| RxCUI: | 1720258
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0359088163542
|
| UPC stands for Universal Product Code. |
| UNII: | 935E97BOY8
9VU1KI44GP
|
| 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: | Vitamin D [CS]
Vitamin D [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 |
|---|
| 59088-163-54 | 30 TABLET in 1 BOTTLE, PLASTIC (59088-163-54) | 10 Jul, 2020 | 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. |
Product Elements:
Folixapure folic acid, vitamin d3 cellulose, microcrystalline lactose monohydrate sodium starch glycolate type a corn magnesium stearate stearic acid folic acid folic acid vitamin d cholecalciferol
Indications and Usage:
Indications and dosage folixapure⢠is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and vitamin d supplementation. folixapure⢠can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
Warnings and Cautions:
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.
Dosage and Administration:
Dosage and administration take one tablet daily or as directed by a healthcare practitioner.
Contraindications:
Contraindications this product is contraindicated in patients with a known hypersensitivity to any of the ingredients. folixapure⢠is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin d, and hypervitaminosis d.
Adverse Reactions:
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.
Description:
Description folixapure⢠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. folixapure⢠should be administered under the supervision of a licensed medical practitioner. each tablet contains: folic acid ..........................................................................1700 mcg dfe (1000 mcg folic acid) vitamin d 3 (cholecalciferol) ......................................125 mcg 5000 iu each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid, magnesium stearate.
Clinical Pharmacology:
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.
How Supplied:
How supplied folixapure⢠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 59088-163-54*). * this product is a prescription-folate with or without other dietary ingredients that â due to increased folate levels (aug 2 1973 fr 20750), requires an rx on the label because of increased risk associated with masking of b 12 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 physicianâs supe
Read more...rvision. there are no implied or explicit claims on therapeutic equivalence
Package Label Principal Display Panel:
Package label / principal display panel manufactured in the usa by: puretek corporation panorama city, ca 91402 for questions or information call toll-free: 877-921-7873 list no. 16354 jpa rev. 36956 label