NDC 0642-7468 Vitafol

Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, And Folic Acid

NDC Product Code 0642-7468

NDC Code: 0642-7468

Proprietary Name: Vitafol 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: Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, And 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.

NDC Code Structure

  • 0642 - Exeltis Usa, Inc.
    • 0642-7468 - Vitafol

NDC 0642-7468-01

Package Description: 3 STRIP in 1 POUCH

NDC 0642-7468-30

Package Description: 30 POUCH in 1 BOX > 1 STRIP in 1 POUCH

NDC Product Information

Vitafol with NDC 0642-7468 is a a human prescription drug product labeled by Exeltis Usa, Inc.. The generic name of Vitafol is cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, and folic acid. The product's dosage form is strip and is administered via oral form.

Labeler Name: Exeltis Usa, Inc.

Dosage Form: Strip - A long narrow piece of material.

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.

Vitafol 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.

  • CHOLECALCIFEROL 1000 [iU]/1
  • PYRIDOXINE HYDROCHLORIDE 2.5 mg/1
  • CYANOCOBALAMIN 12 ug/1
  • FOLIC ACID 1 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • MALTITOL (UNII: D65DG142WK)
  • HYPROMELLOSE 2906 (4000 MPA.S) (UNII: 5EYA69XGAT)
  • ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • 1-METHYLCYCLOHEXA-1,3-DIENE (UNII: NZ9H475GT1)

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 D - [CS]
  • Vitamin D - [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)

Product Labeler Information

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

Labeler Name: Exeltis Usa, Inc.
Labeler Code: 0642
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: 06-15-2019 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: 12-31-2020 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.

Vitafol 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

Composition

Amount per daily dose (1 strip)VITAMINS AND MINERALS:Calories1Total Carbohydrates0 g  Sugars0 gVitamin B6 (as pyridoxine hydrochloride)2.5 mgFolic Acid1 mgVitamin B12 (as cyanocobalamin)12 mcgVitamin D (as cholecalciferol)1000 IUOther Ingredients:Sentry Polyox WSR N80 LEO, maltitol syrup, methocel (hydroxypropyl methylcellulose), sodium citrate anhydrous, lemon flavor, sucralose, butylated hydroxytoluene, peceol, water.

Usage

Vitafol® Strips provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and postnatal period for the lactating and non-lactating women.

Contraindications

Vitafol® Strips 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.Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

Warnings/Precautions

This product is intended for use as directed by your healthcare provider. Please do not share with others.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.Folic acid, especially in doses above 0.1 mg 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.Do not use if inner seal is broken or missing.Do not exceed recommended dose.Keep out of the reach of children.

Drug Interactions

Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.Medications for hypertension used in conjunction with iodine supplementation may increase potassium.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.

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.

Adverse Reactions

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol® Strips. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Directions For Use

Before, during and after pregnancy, take one Vitafol® Strip daily, or as directed by a physician.

How Supplied

Vitafol® Strips is available as an orange rectangular film with "V" logo printed on one side. Available in Box of Unit-Dose pack in pouch of 30 counts, Item No. 0642-7468-30 and as physician sample in pouch of 3 counts, Item No. 0642-7468-01.

Storage And Handling

Store at room temperature, approximately 20°-25°C (68°-77°F), avoid excessive heat, moisture and protect from light.To report suspected adverse event contact Exeltis USA, Inc., at 1-877-324-9349 or at FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Other

Made in USA.Distributed by:Exeltis USA, Inc.Florham Park, NJ 079321-877-324-9349www.exeltisUSA.com©2018 Exeltis USA, Inc.Vitafol® is a trademark of Exeltis USA, Inc.Rev. August 20184683001-01

* Please review the disclaimer below.

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