Multivitamin With Fluoride Tablet, Chewable
NDC Package 58657-165-01

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

Package Information

Multivitamin With Fluoride (.alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d) tablets is a medication a combination product of vitamins and fluoride. This formulation utilizes a tablet, chewable delivery system. Marketed by Method Pharmaceuticals, Llc, this product is identified by NDC 58657-165.

Identification & Billing

NDC Package Code
58657-165-01
Package Description
100 TABLET, CHEWABLE in 1 BOTTLE
Product Code
58657-165
11-Digit Billing Format
58657016501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1364855 - ascorbic acid 60 MG / cholecalciferol 0.01 MG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / thiamine 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - cyanocobalamin 4.5 MCG / folic acid 0.3 MG / niacin 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG (fluoride ion 1 MG) / thiamine 1.05 MG / vitamin A 2500 UNT / vitamin B6 1.05 MG / vitamin C 60 MG / vitamin D 400 UNT / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / nicotinic acid 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vit-B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet
  • RxCUI: 1364855 - vitamin C 60 MG / cholecalciferol 0.01 MG / folate 0.3 MG / vitamin B3 13.5 MG / riboflavin 1.2 MG / sodium fluoride 2.2 MG / vitamin B1 1.05 MG / vitamin A 0.75 MG / vitamin B12 0.0045 MG / vitamin B6 1.05 MG / vitamin E 15 UNT Chewable Tablet

Clinical Specifications

Proprietary Name
Multivitamin With Fluoride
Non-Proprietary Name
.alpha.-tocopherol Acetate, Dl-, Ascorbic Acid, Cyanocobalamin, Folic Acid, Niacin, Pyridoxine, Riboflavin, Sodium Fluoride, Thiamine Mononitrate, Vitamin A And Vitamin D
Substance Name
.alpha.-tocopherol Acetate, Dl-; Ascorbic Acid; Cyanocobalamin; Folic Acid; Niacin; Pyridoxine; Riboflavin; Sodium Fluoride; Thiamine Mononitrate; Vitamin A; Vitamin D
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is a combination product of vitamins and fluoride. It is used in children to treat or prevent deficiency due to poor diet or low levels of fluoride in drinking water and other sources. Vitamins are important building blocks of the body and help keep you in good health. Fluoride is used to prevent dental cavities.

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
07-20-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58657-165). Click a package code to view its specific billing and regulatory data.

58657-165-90
90 TABLET, CHEWABLE in 1 BOTTLE

* 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 58657-165-01 identifies a specific commercial package of 100 tablet, chewable in 1 bottle of Multivitamin With Fluoride, a human prescription drug labeled by Method Pharmaceuticals, Llc. This tablet, chewable is formulated for oral use and contains .alpha.-tocopherol acetate, dl-; ascorbic acid; cyanocobalamin; folic acid; niacin; pyridoxine; riboflavin; sodium fluoride; thiamine mononitrate; 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 20, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a combination product of vitamins and fluoride. It is used in children to treat or prevent deficiency due to poor diet or low levels of fluoride in drinking water and other sources. Vitamins are important building blocks of the body and help keep you in good health. Fluoride is used to prevent dental cavities.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58657016501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
58657-165-01
11-Digit CMS (5-4-2)
58657-0165-01

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