Prescription drug · UNAPPROVED DRUG OTHER
Ionite H (Sodium fluoride, potassium nitrate) NDC 53045-281
Sodium fluoride 1.1 mg/100g; Potassium nitrate 5 mg/100g · Gel, Dentifrice · Dental · Dharma Research, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53045-281-04 | 5304502810453045028104 | 122 g in 1 TUBE (53045-281-04)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.NDC labeler code 53045
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53045-281_ab938727-9383-48ce-a7a6-ed39d7d3ef15SPL ID ab938727-9383-48ce-a7a6-ed39d7d3ef15SPL set ID 642fec99-c5c5-4ef2-986e-5b5f7cf460deRxCUI 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
N453045028104followed by a unit qualifier and the quantityPackage 53045-0281-04. 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 .
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.
About NDC 53045-281
- What is NDC 53045-281?
- 53045-281 is the product NDC for Ionite H, Sodium fluoride 1.1 mg/100g; Potassium nitrate 5 mg/100g gel, dentifrice, listed with the FDA by Dharma Research, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ionite H (Sodium Fluoride, Potassium Nitrate).
- What is the active ingredient?
- Sodium fluoride, Potassium nitrate.
- Who is the labeler?
- Dharma Research, Inc., NDC labeler code 53045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ionite H?
- 5 other product NDCs are listed under this name. See all Ionite H NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ionite H products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ionite Hstannous fluoride | Stannous fluoride .63 mg/100mL | MouthwashDental | Dharma Research, Inc. | 53045-275 | 53045-0275-10 |
| Ionite Hstannous fluoride | Stannous fluoride .63 mg/100mL | MouthwashDental | Dharma Research, Inc. | 53045-276 | 53045-0276-10 |
| Ionite Hstannous fluoride | Stannous fluoride .4 mg/100g | Gel, DentifriceDental | Dharma Research, Inc. | 53045-270 | 53045-0270-04 |
| Ionite Hstannous fluoride | Stannous fluoride .4 mg/100g | Gel, DentifriceDental | Dharma Research, Inc. | 53045-271 | 53045-0271-04 |
| Ionite Hsodium fluoride, potassium nitrate | Sodium fluoride 1.1 mg/100g; Potassium nitrate 5 mg/100g | Gel, DentifriceDental | Dharma Research, Inc. | 53045-280 | 53045-0280-04 |