Prescription drug · UNAPPROVED DRUG OTHER
Burkhart (Stannous fluoride) NDC 43498-201
Stannous fluoride .3408 g/284g · Concentrate · Dental · Burkhart Dental Supply Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43498-201-10 | 43498020110 | 284 g in 1 BOTTLE, PLASTIC (43498-201-10)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 IncNDC labeler code 43498
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 43498-201_d70dc1ee-062b-64d4-e053-2995a90a7559SPL ID d70dc1ee-062b-64d4-e053-2995a90a7559SPL set ID 47142a7d-3095-4ea6-b977-80e9f2cc8958RxCUI 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
N443498020110followed by a unit qualifier and the quantityPackage 43498-0201-10. 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 .
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.
About NDC 43498-201
- What is NDC 43498-201?
- 43498-201 is the product NDC for Burkhart (stannous fluoride), Stannous fluoride .3408 g/284g concentrate, listed with the FDA by Burkhart Dental Supply Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Burkhart (Stannous Fluoride).
- What is the active ingredient?
- Stannous fluoride.
- Who is the labeler?
- Burkhart Dental Supply Inc, NDC labeler code 43498. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Burkhart?
- 13 other product NDCs are listed under this name. See all Burkhart NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Burkhart products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Burkhartstannous fluoride | Stannous fluoride .3408 g/284g | ConcentrateDental | Burkhart Dental Supply Inc | 43498-200 | 43498-0200-10 |
| Burkhartstannous fluoride | Stannous fluoride .116 g/120g | GelDental | Burkhart Dental Supply Inc | 43498-250 | 43498-0250-04 |
| Burkhartstannous fluoride | Stannous fluoride .116 g/120g | GelDental | Burkhart Dental Supply Inc | 43498-251 | 43498-0251-04 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-100 | 43498-0100-15 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-101 | 43498-0101-15 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-102 | 43498-0102-15 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-103 | 43498-0103-15 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-104 | 43498-0104-15 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-105 | 43498-0105-15 |
| Burkhartsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Burkhart Dental Supply Inc | 43498-106 | 43498-0106-15 |