Iris 60 Second APF (sodium fluoride) NDC 66975-051

NDC codes

FDA NDC Directory

Product NDC (as listed)66975-051Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66975-0051Add 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
66975-051-15	66975005115	454 g in 1 BOTTLE, PLASTIC (66975-051-15)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 Dental
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Dec 14, 2012
Listing expires: Dec 31, 2026
Identifiers: Product ID 66975-051_d70c73cb-2203-59a2-e053-2a95a90a13deSPL ID d70c73cb-2203-59a2-e053-2a95a90a13deSPL set ID 6a0f889d-5f27-496f-b830-d778ee867adeRxCUI 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

N466975005115 followed by a unit qualifier and the quantity

Package 66975-0051-15. 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 Feb 2, 2022.

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.

Full label on DailyMed (opens in a new tab)