Prescription drug · UNAPPROVED DRUG OTHER
Sodium Fluoride 5000 ppm Sensitive NDC 11527-704
sodium fluoride1.1%, potassium nitrate 5% · Sodium fluoride 5.8 mg/mL; Potassium nitrate 57.5 mg/mL · Gel, Dentifrice · Dental · Sheffield Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11527-704-42 | 11527070442 | 1 TUBE in 1 CARTON (11527-704-42) / 100 mL in 1 TUBEMarketed from Mar 26, 2020 |
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)
- Sodium Fluoride 5000 ppm Sensitive
- Generic name (nonproprietary)
- sodium fluoride1.1%, potassium nitrate 5%
- Active ingredients
- Sodium fluoride — 5.8 mg/mLPotassium nitrate — 57.5 mg/mL
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 11527-704_c850c90a-b9bc-44b7-b30c-3f297f3ae164SPL ID c850c90a-b9bc-44b7-b30c-3f297f3ae164SPL set ID 02f4cf0b-188c-4522-b759-ffe4a9d150e8UNII 8ZYQ1474W7, RU45X2JN0Z
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
N411527070442followed by a unit qualifier and the quantityPackage 11527-0704-42. 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: A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Sodium Fluoride 5000 ppm Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unles…
Excerpt only. Read the full label for complete information.