Prescription drug · UNAPPROVED DRUG OTHER
Gelato APF (Sodium fluoride) NDC 68400-107
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 |
|---|---|---|---|
| 68400-107-15 | 68400010715 | 454 g in 1 BOTTLE, PLASTIC (68400-107-15)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
- Labeler
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.NDC labeler code 68400
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 68400-107_d5f621e8-9a2d-8add-e053-2a95a90a5ddfSPL ID d5f621e8-9a2d-8add-e053-2a95a90a5ddfSPL set ID 080e7f9d-273e-4f3b-bc84-f7c0dd3cf94cRxCUI 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
N468400010715followed by a unit qualifier and the quantityPackage 68400-0107-15. 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 use.
Excerpt only. Read the full label for complete information.
About NDC 68400-107
- What is NDC 68400-107?
- 68400-107 is the product NDC for Gelato APF (sodium fluoride), Sodium fluoride 5.6 g/454g gel, listed with the FDA by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gelato APF (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc., NDC labeler code 68400. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gelato APF?
- 11 other product NDCs are listed under this name. See all Gelato APF NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gelato APF products
Other finished products listed under the same name: strengths, forms and labelers.