Prescription drug · UNAPPROVED DRUG OTHER
Kolorz Neutral Fluoride Foam Triple Mint (Sodium fluoride) NDC 25047-765
Sodium fluoride .9 mg/g · Aerosol, Foam · Dental · DMG AMERICA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25047-765-44 | 2504707654425047076544 | 125 g in 1 CAN (25047-765-44)Marketed from Nov 22, 2006 |
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)
- Kolorz Neutral Fluoride Foam Triple MintSuffix: TRIPLE MINT
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .9 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Dental
- Labeler
- DMG AMERICA, LLCNDC labeler code 25047
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 25047-765_79be0b6b-34c3-4e14-9702-54e7d4f1104eSPL ID 79be0b6b-34c3-4e14-9702-54e7d4f1104eSPL set ID b83c62be-8e9d-4fa2-aa10-d34c88bf2387RxCUI 688393, 688397UNII 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
N425047076544followed by a unit qualifier and the quantityPackage 25047-0765-44. 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 For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz ® Neutral Foam requires a 4-minute application. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information. Figure
Excerpt only. Read the full label for complete information.
About NDC 25047-765
- What is NDC 25047-765?
- 25047-765 is the product NDC for Kolorz Neutral Fluoride Foam Triple Mint, Sodium fluoride .9 mg/g aerosol, foam, listed with the FDA by DMG AMERICA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kolorz Neutral Fluoride Foam Triple Mint (Sodium fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- DMG AMERICA, LLC, NDC labeler code 25047. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kolorz Neutral Fluoride Foam Triple Mint?
- 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.