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 | 5304502000853045020008 | 245 g in 1 BOTTLE (53045-200-08)Marketed from Jan 1, 2013 | |
| 53045-200-17 | 5304502001753045020017 | 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.NDC labeler code 53045
- 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 .
About NDC 53045-200
- What is NDC 53045-200?
- 53045-200 is the product NDC for Ionite APF (sodium fluoride), Sodium fluoride 10.241 g/490g gel, listed with the FDA by Dharma Research, inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ionite APF (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?
- 7 other product NDCs are listed under this name. See all Ionite APF 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 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 APFsodium fluoride | Sodium fluoride 10.241 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-201 | 53045-0201-0853045-0201-1753045-0201-38 |
| Ionite APFsodium fluoride | Sodium fluoride 6.027 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-202 | 53045-0202-17 |
| Ionite APFsodium fluoride | Sodium fluoride 6.027 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-203 | 53045-0203-17 |
| Ionite APFsodium fluoride | Sodium fluoride 6.027 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-204 | 53045-0204-17 |
| Ionite APFsodium fluoride | Sodium fluoride 6.027 g/490g | GelDental, Oral, Topical | Dharma Research, Inc. | 53045-205 | 53045-0205-17 |
| Ionite APFsodium fluoride | Sodium fluoride 6.027 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-206 | 53045-0206-0853045-0206-17 |
| Ionite APFsodium fluoride | Sodium fluoride 6.027 g/490g | GelDental, Oral | Dharma Research, inc. | 53045-207 | 53045-0207-17 |