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  5. NDC Package Code: 82091-116-01 Kaylaan

NDC Package 82091-116-01 Kaylaan

Zero Waste Refill For Toothpaste Tablet, Chewable Dental - 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:
82091-116-01
Package Description:
74.3 mg in 1 BOX, UNIT-DOSE
Product Code:
82091-116
Proprietary Name:
Kaylaan
Non-Proprietary Name:
Zero Waste Refill For Toothpaste
Substance Name:
Sodium Fluoride
11-Digit NDC Billing Format:
82091011601
Product Type:
Human Otc Drug
Labeler Name:
Kaylaan Llc
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(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .37 mg/440mg
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    09-13-2021
    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 82091-116-01?

    The NDC Packaged Code 82091-116-01 is assigned to a package of 74.3 mg in 1 box, unit-dose of Kaylaan, a human over the counter drug labeled by Kaylaan Llc. The product's dosage form is tablet, chewable and is administered via dental form.

    Is NDC 82091-116 included in the NDC Directory?

    Yes, Kaylaan with product code 82091-116 is active and included in the NDC Directory. The product was first marketed by Kaylaan Llc on September 13, 2021 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 11-digit format for NDC 82091-116-01?

    The 11-digit format is 82091011601. 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
    5-3-282091-116-015-4-282091-0116-01