Tri-vite Drops With Fluoride Solution
NDC Package 58657-324-50

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tri-vite Drops With Fluoride (ascorbic acid, sodium fluoride, vitamin a and vitamin d) solution is supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.5 mg also provides fluoride for caries prophylaxis.The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.5 mg (See Dosage and Administration).Tri-Vite Drops with Fluoride 0.5 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride. This formulation utilizes a solution delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-324.

Identification & Billing

NDC Package Code
58657-324-50
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 50 mL in 1 BOTTLE, DROPPER
Product Code
58657-324
11-Digit Billing Format
58657032450
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1365984 - ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
  • RxCUI: 1365984 - ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / retinyl palmitate 1500 UNT/ML / sodium fluoride 1.1 MG/ML Oral Solution
  • RxCUI: 1365984 - sodium fluoride 1.1 MG (fluoride ion 0.5 MG) / vitamin A palmitate 1500 UNT / vitamin C 35 MG / vitamin D3 0.01 MG (400 UNT) per ML Oral Solution
  • RxCUI: 1365984 - vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
  • RxCUI: 1365984 - vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution

Clinical Specifications

Proprietary Name
Tri-vite Drops With Fluoride
Non-Proprietary Name
Ascorbic Acid, Sodium Fluoride, Vitamin A And Vitamin D
Substance Name
Ascorbic Acid; Sodium Fluoride; Vitamin A; Vitamin D
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.5 mg also provides fluoride for caries prophylaxis.The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.5 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.5 mg (See Dosage and Administration).Tri-Vite Drops with Fluoride 0.5 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride.

Regulatory & Marketing

Labeler Name
Method Pharmaceuticals, Llc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-25-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58657-324-50 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 50 ml in 1 bottle, dropper of Tri-vite Drops With Fluoride, a human prescription drug labeled by Method Pharmaceuticals, Llc. This solution is formulated for oral use and contains ascorbic acid; sodium fluoride; vitamin a; vitamin d as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Method Pharmaceuticals, Llc on July 25, 2018. The current certification is valid through December 31, 2026.

How is this Method Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657032450. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
58657-324-50
11-Digit CMS (5-4-2)
58657-0324-50

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.