Prescription drug · UNAPPROVED DRUG OTHER
Iris 60 Second APF (Sodium fluoride) NDC 66975-054
Sodium fluoride 5.6 g/454g · Gel · Dental · Benco Dental
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66975-054-15 | 6697500541566975005415 | 454 g in 1 BOTTLE, PLASTIC (66975-054-15)Marketed from May 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)
- Iris 60 Second APF
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 5.6 g/454g
- Dosage form
- Gel
- Route
- Dental
- Labeler
- Benco DentalNDC labeler code 66975
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 66975-054_d70c8143-4a70-9538-e053-2a95a90a059cSPL ID d70c8143-4a70-9538-e053-2a95a90a059cSPL set ID d5658bf8-3a13-4d8b-b727-5f1575919571RxCUI 245593UNII 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
N466975005415followed by a unit qualifier and the quantityPackage 66975-0054-15. 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.
About NDC 66975-054
- What is NDC 66975-054?
- 66975-054 is the product NDC for Iris 60 Second APF (sodium fluoride), Sodium fluoride 5.6 g/454g gel, listed with the FDA by Benco Dental. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Iris 60 Second APF (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Benco Dental, NDC labeler code 66975. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Iris 60 Second APF?
- 4 other product NDCs are listed under this name. See all Iris 60 Second APF NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Iris 60 Second APF products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Iris 60 Second APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Benco Dental | 66975-050 | 66975-0050-15 |
| Iris 60 Second APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Benco Dental | 66975-051 | 66975-0051-15 |
| Iris 60 Second APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Benco Dental | 66975-052 | 66975-0052-15 |
| Iris 60 Second APFsodium fluoride | Sodium fluoride 5.6 g/454g | GelDental | Benco Dental | 66975-053 | 66975-0053-15 |