NDC 43498-200

Burkhart

Stannous Fluoride

Burkhart is a Dental Concentrate in the Human Prescription Drug category. It is labeled and distributed by Burkhart Dental Supply Inc. The primary component is Stannous Fluoride.

Product ID43498-200_26a314c2-c2b9-4c1f-9f82-010aaa98e498
NDC43498-200
Product TypeHuman Prescription Drug
Proprietary NameBurkhart
Generic NameStannous Fluoride
Dosage FormConcentrate
Route of AdministrationDENTAL
Marketing Start Date2013-02-01
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameBurkhart Dental Supply Inc
Substance NameSTANNOUS FLUORIDE
Active Ingredient Strength0 g/284g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43498-200-10

284 g in 1 BOTTLE, PLASTIC (43498-200-10)
Marketing Start Date2013-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43498-200-10 [43498020010]

Burkhart CONCENTRATE
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-01

Drug Details

Active Ingredients

IngredientStrength
STANNOUS FLUORIDE.3408 g/284g

OpenFDA Data

SPL SET ID:de19f0ea-7446-493d-b766-c678c727a1af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 583459
  • NDC Crossover Matching brand name "Burkhart" or generic name "Stannous Fluoride"

    NDCBrand NameGeneric Name
    43498-108BurkhartBurkhart
    43498-103BurkhartBurkhart
    43498-106BurkhartBurkhart
    43498-109BurkhartBurkhart
    43498-104BurkhartBurkhart
    43498-100BurkhartBurkhart
    43498-200BurkhartBurkhart
    43498-102BurkhartBurkhart
    43498-105BurkhartBurkhart
    43498-107BurkhartBurkhart
    43498-101BurkhartBurkhart
    43498-201BurkhartBurkhart
    43498-250BurkhartBurkhart
    43498-251BurkhartBurkhart
    0126-0165Gel-Kam Fruit and BerryStannous Fluoride
    0126-0192Gel-Kam MintStannous Fluoride
    0135-0598parodontaxstannous fluoride
    0135-0599parodontaxstannous fluoride
    0135-0601parodontaxstannous fluoride
    0135-0547SENSODYNEstannous fluoride
    0135-0548SENSODYNEstannous fluoride
    0135-0575SENSODYNEstannous fluoride
    0135-0621SENSODYNEstannous fluoride
    0135-0622SENSODYNEstannous fluoride
    0135-0572Sensodyne Complete Protectionstannous fluoride
    0135-0573Sensodyne Complete Protectionstannous fluoride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.