Prescription drug · UNAPPROVED DRUG OTHER
Gelato APF (sodium fluoride) NDC 68400-110
Sodium fluoride 5.6 g/454g · Gel · Dental · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68400-110-15 | 68400011015 | 454 g in 1 BOTTLE, PLASTIC (68400-110-15)Marketed from Jun 1, 2016 |
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)
- Gelato APF
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 5.6 g/454g
- Dosage form
- Gel
- Route
- Dental
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 68400-110_d5f4f5b4-2d8a-6c1b-e053-2995a90ab23bSPL ID d5f4f5b4-2d8a-6c1b-e053-2995a90ab23bSPL set ID 6c1907d6-5b22-40fc-b94e-42af7b523902RxCUI 245593, 656838UNII 8ZYQ1474W7
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
N468400011015followed by a unit qualifier and the quantityPackage 68400-0110-15. 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: A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Excerpt only. Read the full label for complete information.