Prescription drug · UNAPPROVED DRUG OTHER
Fluoridex (Sodium fluoride) NDC 59883-016
Sodium fluoride 5 mg/g · Paste, Dentifrice · Dental · DEN-MAT HOLDINGS, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59883-016-04 | 5988300160459883001604 | 1 TUBE in 1 BOX (59883-016-04) / 112 g in 1 TUBEMarketed from Dec 30, 2016 |
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)
- Fluoridex
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 5 mg/g
- Dosage form
- Paste, Dentifrice
- Route
- Dental
- Labeler
- DEN-MAT HOLDINGS, LLC.NDC labeler code 59883
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 59883-016_82f8ac58-f95d-255b-e053-2a91aa0aceb7SPL ID 82f8ac58-f95d-255b-e053-2a91aa0aceb7SPL set ID 5fd60635-4b66-15e3-e053-2991aa0ab23aUNII 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
N459883001604followed by a unit qualifier and the quantityPackage 59883-0016-04. 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)
Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
Excerpt only. Read the full label for complete information.
About NDC 59883-016
- What is NDC 59883-016?
- 59883-016 is the product NDC for Fluoridex (sodium fluoride), Sodium fluoride 5 mg/g paste, dentifrice, listed with the FDA by DEN-MAT HOLDINGS, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluoridex (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- DEN-MAT HOLDINGS, LLC., NDC labeler code 59883. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluoridex?
- 4 other product NDCs are listed under this name. See all Fluoridex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluoridex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluoridexsodium fluoride | Sodium fluoride 5 mg/g; Potassium nitrate 50 mg/g | Paste, DentifriceDental | DENT-MAT HOLDINGS, LLC. | 59883-030 | 59883-0030-04 |
| Fluoridexsodium fluoride | Sodium fluoride 5 mg/g | Paste, DentifriceDental | DEN-MAT HOLDINGS, LLC. | 59883-020 | 59883-0020-04 |
| Fluoridexsodium fluoride | Potassium nitrate 50 mg/g; Sodium fluoride 5 mg/g | Paste, DentifriceDental | DENT-MAT HOLDINGS, LLC. | 59883-031 | 59883-0031-0459883-0031-05 |
| Fluoridexstannous fluoride rinse | Stannous fluoride 1.53 mg/g | LiquidOral | DEN-MAT HOLDINGS, LLC | 59883-004 | 59883-0004-01 |