Prescription drug · UNAPPROVED DRUG OTHER
PreviDent 5000 Dry Mouth (sodium fluoride) NDC 0126-0016
Sodium fluoride 6.1 mg/mL · Gel, Dentifrice · Dental · Colgate Oral Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0126-0016-61 | 00126001661 | 100 mL in 1 BOTTLE (0126-0016-61)Marketed from Jul 6, 2009 |
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 Dry MouthSuffix: 5000 Dry Mouth
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 6.1 mg/mL
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 0126-0016_8f71eedc-1ece-48c0-9130-48ca61d872fcSPL ID 8f71eedc-1ece-48c0-9130-48ca61d872fcSPL set ID d93ee76f-454b-40bf-9357-39a2ae3b6ccbRxCUI 392038, 630194UNII 8ZYQ1474W7UPC 0301260016610
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
N400126001661followed by a unit qualifier and the quantityPackage 00126-0016-61. 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 once daily self-applied topical use. 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 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once 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.