Prescription drug · UNAPPROVED DRUG OTHER
Ionite APF Neutral (Sodium fluoride) NDC 53045-237
Sodium fluoride 4.41 g/490g · Gel · Dental, Oral, Topical · Dharma Research, inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53045-237-17 | 5304502371753045023717 | 490 g in 1 BOTTLE (53045-237-17)Marketed from Jan 1, 2013 |
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 APF NeutralSuffix: Neutral
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 4.41 g/490g
- Dosage form
- Gel
- Route
- Dental, Oral, Topical
- Labeler
- Dharma Research, inc.NDC labeler code 53045
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53045-237_aed31a6c-2771-41cf-a35a-785e4a776366SPL ID aed31a6c-2771-41cf-a35a-785e4a776366SPL set ID 8191554f-adb6-4ba9-aa80-0a9bb65193ecUNII 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
N453045023717followed by a unit qualifier and the quantityPackage 53045-0237-17. 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 .
About NDC 53045-237
- What is NDC 53045-237?
- 53045-237 is the product NDC for Ionite APF Neutral (sodium fluoride), Sodium fluoride 4.41 g/490g gel, 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 APF Neutral (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- 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 APF Neutral?
- 1 other product NDC are listed under this name. See all Ionite APF Neutral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ionite APF Neutral 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 APF Neutralsodium fluoride | Sodium fluoride 4.41 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-235 | 53045-0235-17 |