Burkhart (stannous fluoride) NDC 43498-200

NDC codes

FDA NDC Directory

Product NDC (as listed)43498-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43498-0200Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43498-200-10	43498020010	284 g in 1 BOTTLE, PLASTIC (43498-200-10)Marketed from Sep 1, 2013

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Burkhart
Generic name (nonproprietary): stannous fluoride
Active ingredients: Stannous fluoride — .3408 g/284g
Dosage form: Concentrate
Route: Dental
Labeler: Burkhart Dental Supply Inc
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Feb 1, 2013
Listing expires: Dec 31, 2026
Identifiers: Product ID 43498-200_d70dcc83-25ca-3eb9-e053-2a95a90a5c02SPL ID d70dcc83-25ca-3eb9-e053-2a95a90a5c02SPL set ID de19f0ea-7446-493d-b766-c678c727a1afRxCUI 583459UNII 3FTR44B32Q

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N443498020010 followed by a unit qualifier and the quantity

Package 43498-0200-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Feb 2, 2022.

Indications (excerpt from the label)

Indications and Usage: Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)