Prescription drug · UNAPPROVED DRUG OTHER
Sodium Fluoride 5000 ppm Enamel Protect NDC 11527-745
sodium fluoride1.1%, potassium nitrate 5% · Potassium nitrate 57.5 mg/mL; Sodium fluoride 5.8 mg/mL · Gel, Dentifrice · Dental · Sheffield Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11527-745-34 | 1152707453411527074534 | 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBEMarketed from Jan 8, 2021 |
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 Enamel Protect
- Generic name (nonproprietary)
- sodium fluoride1.1%, potassium nitrate 5%
- Active ingredients
- Potassium nitrate — 57.5 mg/mLSodium fluoride — 5.8 mg/mL
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Labeler
- Sheffield Pharmaceuticals LLCNDC labeler code 11527
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480SPL ID 3fa71e96-0c84-4ce6-8aa8-6689b876c480SPL set ID 83dfdead-4f71-404e-90ae-dbd6849c7cf1UNII RU45X2JN0Z, 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
N411527074534followed by a unit qualifier and the quantityPackage 11527-0745-34. 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 teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, 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 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toot…
Excerpt only. Read the full label for complete information.
About NDC 11527-745
- What is NDC 11527-745?
- 11527-745 is the product NDC for Sodium Fluoride 5000 ppm Enamel Protect, Potassium nitrate 57.5 mg/mL; Sodium fluoride 5.8 mg/mL gel, dentifrice, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Fluoride 5000 ppm Enamel Protect (Sodium Fluoride1.1%, Potassium Nitrate 5%).
- What is the active ingredient?
- Potassium nitrate, Sodium fluoride.
- Who is the labeler?
- Sheffield Pharmaceuticals LLC, NDC labeler code 11527. 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 5000 ppm Enamel Protect?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.