Ionite H NDC 53045-280

NDC codes

FDA NDC Directory

Product NDC (as listed)53045-280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53045-0280Add 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
53045-280-04	53045028004	122 g in 1 TUBE (53045-280-04)Marketed from Aug 2, 2015

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): Ionite H
Generic name (nonproprietary): sodium fluoride, potassium nitrate
Active ingredients: Sodium fluoride — 1.1 mg/100gPotassium nitrate — 5 mg/100g
Dosage form: Gel, Dentifrice
Route: Dental
Labeler: Dharma Research, Inc.
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Aug 2, 2015
Listing expires: Dec 31, 2026
Identifiers: Product ID 53045-280_0b21c890-82f5-4e90-8aa1-1e06d631760eSPL ID 0b21c890-82f5-4e90-8aa1-1e06d631760eSPL set ID 54c1a27c-5936-4ee2-a419-3891d3df9745RxCUI 637365UNII 8ZYQ1474W7, RU45X2JN0Z

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

N453045028004 followed by a unit qualifier and the quantity

Package 53045-0280-04. 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 Aug 2, 2015.

Indications (excerpt from the label)

INDICATIONS AND USAGE This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)