Burkhart

Product NDC
43498-200
11-digit product format
434980200
Labeler code
43498
Product ID
43498-200_d70dcc83-25ca-3eb9-e053-2a95a90a5c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
CONCENTRATE
Route
DENTAL
Labeler
Burkhart Dental Supply Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-02-01
Substance
STANNOUS FLUORIDE
Active strength
.3408 g/284g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Burkhart
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.3408 g/284g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui583459

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43498-200-10Burkhart284 g in 1 BOTTLE, PLASTICCONCENTRATE2843

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-200BURKHART (STANNOUS FLUORIDE) CONCENTRATE [BURKHART DENTAL SUPPLY INC]3Current NDC, Legacy NDC, 1 package rows20220203_de19f0ea-7446-493d-b766-c678c727a1af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583459stannous fluoride 0.63 % Dental SolutionPSNde19f0ea-7446-493d-b766-c678c727a1af3
583459stannous fluoride 6.3 MG/ML MouthwashSCDde19f0ea-7446-493d-b766-c678c727a1af3
583459stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental SolutionSYde19f0ea-7446-493d-b766-c678c727a1af3
583459stannous fluoride 0.63 % Dental SolutionSYde19f0ea-7446-493d-b766-c678c727a1af3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-200-1043498020010284 g in 1 BOTTLE, PLASTIC (43498-200-10) 284 g2013-09-010000-00-00NoNoCurrent