Floriva

Cholecalciferol And Sodium Fluoride

Bongeo Pharmaceuticals, Inc.
Human Prescription Drug
NDC 52796-172

Floriva also known as Cholecalciferol And Sodium Fluoride is a human prescription drug labeled by 'Bongeo Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Floriva is 52796-172. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Floriva drug includes Cholecalciferol - 400 [iU]/mL Sodium Fluoride - .25 mg/mL . The currest status of Floriva drug is Active.

Drug Information:

Drug NDC:	52796-172
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:	Floriva
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:	Cholecalciferol And Sodium Fluoride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bongeo Pharmaceuticals, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
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 - 400 [iU]/mL SODIUM FLUORIDE - .25 mg/mL
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:	15 Oct, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 Jun, 2026
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, 2023
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:	BonGeo Pharmaceuticals, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1596005
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.
NUI:	M0022797 N0000175952
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	1C6V77QF41 8ZYQ1474W7
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]
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]
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:	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
52796-172-50	1 BOTTLE, DROPPER in 1 BOX (52796-172-50) / 50 mL in 1 BOTTLE, DROPPER	15 Oct, 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.

Other medicines with the same generic name

Floriva

Cholecalciferol And Sodium Fluoride

Liquid
BonGeo Pharmaceuticals, Inc.
NDC: 52796-172

Product Elements:

Floriva cholecalciferol and sodium fluoride cholecalciferol cholecalciferol sodium fluoride fluoride ion glycerin water polysorbate 80 sodium hydroxide propylene glycol sucralose methylparaben propylparaben

Indications and Usage:

How to use fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. the full dose will be given. it is normal for a small amount to remain in the tip of the dropper. do not accept if tamper evident box seal is broken or missing. the manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

Warnings:

Warning keep this product out of the reach of children. if overdosage is suspected, seek professional assistance or contact a poison control center immediately 1-800-222-1222. shake well before use

Dosage and Administration:

Directions use as directed by a physician

Description:

Supplement facts serving size: 1 ml servings per container: 50 amount per serving % daily value percent daily value (%dv) based on a 2000 calorie diet. vitamin d 400 iu 100% fluoride (sodium fluoride) 0.25 mg daily value not established. other ingredients: glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben.

Package Label Principal Display Panel:

Principal display panel - 50 ml bottle label 52796-172-50 bongeo â¢ pharmaceuticals floriva â¢ 0.25 mg drops 0.25 mg* fluoride drops fluoride and vitamin d liquid drops fruit flavor rx dietary supplement 1 2/3 fl. oz (50 ml) sugar, saccharin and gluten free no artificial colors or dyes *contains 0.25 mg fluoride from 0.55 mg sodium fluoride principal display panel - 50 ml bottle label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.