Prescription drug · UNAPPROVED DRUG OTHER
PreviDent 5000 Enamel Protect (Sodium fluoride and potassium nitrate) NDC 0126-0022
Sodium fluoride 5.8 mg/mL; Potassium nitrate 57.5 mg/mL · Gel, Dentifrice · Dental · Colgate Oral Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0126-0022-92 | 0012600229200126002292 | 100 mL in 1 BOTTLE (0126-0022-92)Marketed from Mar 30, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- PreviDent 5000 Enamel Protect
- Generic name (nonproprietary)
- sodium fluoride and potassium nitrate
- Active ingredients
- Sodium fluoride — 5.8 mg/mLPotassium nitrate — 57.5 mg/mL
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Labeler
- Colgate Oral Pharmaceuticals, Inc.NDC labeler code 0126
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 0126-0022_3b6e8b51-0682-4bce-9df3-bf3c62f132c2SPL ID 3b6e8b51-0682-4bce-9df3-bf3c62f132c2SPL set ID bbc66b1b-e05c-4e14-bef3-b8bae419fc89UNII 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
N400126002292followed by a unit qualifier and the quantityPackage 00126-0022-92. 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 adult 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 PreviDent ® 5000 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle 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 0126-0022
- What is NDC 0126-0022?
- 0126-0022 is the product NDC for PreviDent 5000 Enamel Protect, Sodium fluoride 5.8 mg/mL; Potassium nitrate 57.5 mg/mL gel, dentifrice, listed with the FDA by Colgate Oral Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PreviDent 5000 Enamel Protect (SODIUM FLUORIDE and POTASSIUM NITRATE).
- What is the active ingredient?
- Sodium fluoride, Potassium nitrate.
- Who is the labeler?
- Colgate Oral Pharmaceuticals, Inc., NDC labeler code 0126. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PreviDent 5000 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.