Prescription drug · UNAPPROVED DRUG OTHER
PreviDent OrthoDefense (Sodium fluoride) NDC 0126-0289
Sodium fluoride 6 mg/mL · Paste, Dentifrice · Dental · Colgate Oral Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0126-0289-92 | 0012602899200126028992 | 100 mL in 1 BOTTLE (0126-0289-92)Marketed from Mar 7, 2019 |
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 OrthoDefense
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 6 mg/mL
- Dosage form
- Paste, 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 0126-0289_a3031872-981f-442a-982b-0837d3bea67fSPL ID a3031872-981f-442a-982b-0837d3bea67fSPL set ID 99d37f3e-ac4f-4e8f-92e3-9b27d7632d35RxCUI 392038, 630194UNII 8ZYQ1474W7UPC 0301260289922
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
N400126028992followed by a unit qualifier and the quantityPackage 00126-0289-92. 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; for twice daily self-applied topical use. PreviDent® 5000 Ortho Defense™ 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Excerpt only. Read the full label for complete information.
About NDC 0126-0289
- What is NDC 0126-0289?
- 0126-0289 is the product NDC for PreviDent OrthoDefense (sodium fluoride), Sodium fluoride 6 mg/mL paste, 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 OrthoDefense (Sodium fluoride).
- What is the active ingredient?
- Sodium fluoride.
- 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 OrthoDefense?
- 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.