Prescription drug · UNAPPROVED DRUG OTHER
Fluoride (Sodium fluoride) NDC 75826-163
Sodium fluoride .25 mg/1 · Tablet, Chewable · Oral · WINDER LABORATORIES, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75826-163-20 | 7582601632075826016320 | 120 TABLET, CHEWABLE in 1 BOTTLE (75826-163-20)Marketed from Jan 1, 2024 |
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)
- Fluoride
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .25 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- WINDER LABORATORIES, LLCNDC labeler code 75826
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 75826-163_47a68277-53e0-538f-e063-6394a90aa82cSPL ID 47a68277-53e0-538f-e063-6394a90aa82cSPL set ID 0df8f1aa-f3ef-9f59-e063-6294a90a0666RxCUI 198215, 313036, 315213UNII 8ZYQ1474W7UPC 0375826165203, 0375826163209, 0375826164206
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N475826016320followed by a unit qualifier and the quantityPackage 75826-0163-20. 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 For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.
Excerpt only. Read the full label for complete information.
About NDC 75826-163
- What is NDC 75826-163?
- 75826-163 is the product NDC for Fluoride (sodium fluoride), Sodium fluoride .25 mg/1 tablet, chewable, listed with the FDA by WINDER LABORATORIES, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluoride (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- WINDER LABORATORIES, LLC, NDC labeler code 75826. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluoride?
- 4 other product NDCs are listed under this name. See all Fluoride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluoride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluoridesodium fluoride | Sodium fluoride .22 g/g | PasteDental | McKesson | 68599-9573 | 68599-9573-0168599-9573-0268599-9573-03+1 more |
| Fluoridefluoride toothpaste | Sodium monofluorophosphate .76 g/g | PasteDental | McKesson | 68599-9571 | 68599-9571-01 |
| Fluoridesodium fluoride | Sodium fluoride .5 mg/1 | Tablet, ChewableOral | WINDER LABORATORIES, LLC | 75826-164 | 75826-0164-20 |
| Fluoridesodium fluoride | Sodium fluoride 1 mg/1 | Tablet, ChewableOral | WINDER LABORATORIES, LLC | 75826-165 | 75826-0165-20 |