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  5. NDC Package Code: 58657-323-50 Tri-vite Drops With Fluoride

NDC Package 58657-323-50 Tri-vite Drops With Fluoride

Ascorbic Acid,Sodium Fluoride,Vitamin A And Vitamin D Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58657-323-50
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 50 mL in 1 BOTTLE, DROPPER
Product Code:
58657-323
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
Usage Information:
Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis.The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. 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 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.25 mg (See Dosage and Administration).Tri-Vite Drops with Fluoride 0.25 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.
11-Digit NDC Billing Format:
58657032350
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1365980 - vitamin C 35 MG/mL / cholecalciferol 0.01 MG/mL / sodium fluoride 0.55 MG/mL / vitamin A palmitate 450 MCG/mL Oral Solution
  • RxCUI: 1365980 - ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
  • RxCUI: 1365980 - sodium fluoride 0.55 MG (fluoride ion 0.25 MG) / vitamin A palmitate 450 MCG (1500 UNT) / vitamin C 35 MG / vitamin D3 10 MCG (400 UNT) per ML Oral Solution
  • RxCUI: 1365980 - vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
  • RxCUI: 1365980 - vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Method Pharmaceuticals, Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ASCORBIC ACID 35 mg/mL
  • SODIUM FLUORIDE .25 mg/mL
  • VITAMIN A 1500 [iU]/mL
  • VITAMIN D 400 [iU]/mL
    • Pharmacologic Class(es):
  • Ascorbic Acid - [CS]
  • Vitamin A - [CS]
  • Vitamin A - [EPC] (Established Pharmacologic Class)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 58657-323-50?

    The NDC Packaged Code 58657-323-50 is assigned to a 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. The product's dosage form is solution and is administered via oral form.

    Is NDC 58657-323 included in the NDC Directory?

    Yes, Tri-vite Drops With Fluoride with product code 58657-323 is active and included in the NDC Directory. The product was first marketed by Method Pharmaceuticals, Llc on July 25, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 58657-323-50?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 58657-323-50?

    The 11-digit format is 58657032350. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-258657-323-505-4-258657-0323-50