Prescription drug · UNAPPROVED DRUG OTHER
Ionite APF (sodium fluoride) NDC 53045-200
Sodium fluoride 10.241 g/490g · Gel · Dental, Oral · Dharma Research, inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53045-200-08 | 53045020008 | 245 g in 1 BOTTLE (53045-200-08)Marketed from Jan 1, 2013 | |
| 53045-200-17 | 53045020017 | 490 g in 1 BOTTLE (53045-200-17)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
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 10.241 g/490g
- Dosage form
- Gel
- Route
- Dental, Oral
- Labeler
- Dharma Research, inc.
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 53045-200_e3e37317-62bd-4365-8bac-cf99db614201SPL ID e3e37317-62bd-4365-8bac-cf99db614201SPL set ID 503ca71a-f50c-4406-b925-5b6ac36a9212RxCUI 245593UNII 8ZYQ1474W7UPC 0353045000222
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
N453045020008followed by a unit qualifier and the quantityPackage 53045-0200-08. 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 .