Vitafol Nano
Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine
Exeltis Usa, Inc.
Human Prescription Drug
NDC 0642-0094Vitafol Nano also known as Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine is a human prescription drug labeled by 'Exeltis Usa, Inc.'. National Drug Code (NDC) number for Vitafol Nano is 0642-0094. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Vitafol Nano drug includes Cholecalciferol - 25 ug/1 Cyanocobalamin - 12 ug/1 Folic Acid - 680 ug/1 Iodine - 150 ug/1 Iron - 18 mg/1 Levomefolate Calcium - 1020 ug/1 Pyridoxine Hydrochloride - 2.5 mg/1 . The currest status of Vitafol Nano drug is Active.
Drug Information:
| Drug NDC: | 0642-0094 |
| 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: | Vitafol Nano |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Vitafol |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Nano |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Cholecalciferol, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, And Iodine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Exeltis Usa, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| 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: | CHOLECALCIFEROL - 25 ug/1
CYANOCOBALAMIN - 12 ug/1
FOLIC ACID - 680 ug/1
IODINE - 150 ug/1
IRON - 18 mg/1
LEVOMEFOLATE CALCIUM - 1020 ug/1
PYRIDOXINE HYDROCHLORIDE - 2.5 mg/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: | 14 Jul, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 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: | Exeltis USA, Inc.
|
| 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. |
| NUI: | M0022797
N0000175952
M0022794
N0000175951
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 1C6V77QF41
P6YC3EG204
935E97BOY8
9679TC07X4
E1UOL152H7
A9R10K3F2F
68Y4CF58BV
|
| 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 D [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 D [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]
Vitamin B 12 [CS]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B12 [EPC]
Vitamin B6 Analog [EPC]
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 |
|---|
| 0642-0094-01 | 30 TABLET, COATED in 1 BOTTLE (0642-0094-01) | 14 Jul, 2014 | N/A | No |
| 0642-0094-03 | 3 TABLET, COATED in 1 BLISTER PACK (0642-0094-03) | 14 Jul, 2014 | 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:
Vitafol nano cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine microcrystalline cellulose hydroxypropyl cellulose (1600000 wamw) croscarmellose sodium magnesium stearate sucrose silicon dioxide anhydrous dibasic calcium phosphate polyvinyl alcohol, unspecified titanium dioxide polyethylene glycol, unspecified talc sodium ascorbate medium-chain triglycerides .alpha.-tocopherol, dl- sucralose fd&c blue no. 2 cholecalciferol cholecalciferol pyridoxine hydrochloride pyridoxine folic acid folic acid levomefolate calcium levomefolic acid cyanocobalamin cyanocobalamin iron iron iodine iodine ev0094
Drug Interactions:
Drug interactions high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. folic acid may decrease a patient's response to methotrexate. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. consult appropriate references for additional specific vitamin-drug interactions.
Boxed Warning:
Warning 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 a poison control center immediately.
Indications and Usage:
Usage vitafol ® -nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.
Warnings and Cautions:
Warnings/precautions vitamin d supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. high doses of vitamin d can lead to elevated levels of calcium that reside in the blood and soft tissues. bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. prolonged use of iron salts may produce iron storage disease. folate, especially in doses above 1700 mcg dfe (1000 mcg folic acid) daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. the use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin b12 deficiency. avoid overdosage. keep out of the reach of children. drug interactions high doses of folic acid may result in decreased serum levels of the anticonvulsant
Read more... drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. folic acid may decrease a patient's response to methotrexate. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. consult appropriate references for additional specific vitamin-drug interactions. information for patients patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. pediatric use not for pediatric use.
Dosage and Administration:
Directions for use before, during and after pregnancy, one tablet daily, or as directed by a physician.
Contraindications:
Contraindications vitafol ® -nano is contraindicated in patients with hypersensitivity to any of its components or color additives. folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin b12).
Adverse Reactions:
Adverse reactions adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in vitafol ® -nano. however, allergic and idiosyncratic reactions are possible at any dose. reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
Drug Interactions:
Drug interactions high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. folic acid may decrease a patient's response to methotrexate. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. consult appropriate references for additional specific vitamin-drug interactions.
Pediatric Use:
Pediatric use not for pediatric use.
Description:
Composition amount per tablet: vitamins and minerals vitamin d (as cholecalciferol) 25 mcg vitamin b6 (as pyridoxine hydrochloride) 2.5 mg folate (as folic acid usp 680 mcg dfe and l-methylfolate calcium 1020 mcg dfe, as metafolin ® cas# 151533-22-1) 1700 mcg dfe vitamin b12 (as cyanocobalamin) 12 mcg iron (as ferrous fumarate) 18 mg iodine (as potassium iodide) 150 mcg other ingredients microcrystalline cellulose, hydroxypropylcellulose, modified food starch, croscarmellose sodium, magnesium stearate, sucrose, silicon dioxide, dibasic calcium phosphate, polyvinyl alcohol, titanium dioxide (as color), polyethylene glycol, talc, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, sucralose, fd&c blue #2 aluminum lake.
How Supplied:
How supplied vitafol ® -nano is available as a light blue, round tablet imprinted with "94" on one side. available in 30 cts in hdpe bottle, 0642-0094-01. store at room temperature approximately 20°-25°c (68°-77°f). avoid excessive heat, light, moisture and humidity.
Information for Patients:
Information for patients patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Package Label Principal Display Panel:
Principal display panel - 30 tablet bottle label 0642-0094-01 vitafol nano smallest prenatal supplement with essential nutrients 30 tablets r x dietary supplement principal display panel - 30 tablet bottle label