Prescription drug · UNAPPROVED DRUG OTHER
Sodium Fluoride Chewable (Sodium fluoride) NDC 63629-1133
Sodium fluoride 1 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1133-1 | 63629113301 | 120 TABLET in 1 BOTTLE (63629-1133-1)Marketed from Oct 6, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Sodium Fluoride Chewable
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-1133_ceffded9-9ae7-45dc-8a60-3164c534be28SPL ID ceffded9-9ae7-45dc-8a60-3164c534be28SPL set ID 4ce32ee3-cd20-4663-a169-fa78ebd20477RxCUI 315213UNII 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 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
N463629113301followed by a unit qualifier and the quantityPackage 63629-1133-01. 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 63629-1133
- What is NDC 63629-1133?
- 63629-1133 is the product NDC for Sodium Fluoride Chewable (sodium fluoride), Sodium fluoride 1 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Fluoride Chewable (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Fluoride Chewable?
- 10 other product NDCs are listed under this name. See all Sodium Fluoride Chewable NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Fluoride Chewable products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .25 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-160 | 58657-0160-12 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-161 | 58657-0161-1058657-0161-12 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride 1 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-162 | 58657-0162-12 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1130 | 63629-1130-01 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1131 | 63629-1131-01 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1132 | 63629-1132-01 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2724 | 71335-2724-01 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1652 | 72162-1652-02 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride .5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1653 | 72162-1653-0072162-1653-02 |
| Sodium Fluoride Chewablesodium fluoride | Sodium fluoride 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1654 | 72162-1654-02 |