NDC codes

FDA NDC Directory
Product NDC (as listed)25047-772Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25047-0772Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
25047-772-162504707721625047077216480 mL in 1 BOTTLE (25047-772-16)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 Sixty Second Fluoride Cherry CheesecakeSuffix: CHERRY CHEESECAKE
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 12.3 mg/mL
Dosage form
Gel
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 25047-772_f15de5cf-4f64-472b-bda4-87daed17c864SPL ID f15de5cf-4f64-472b-bda4-87daed17c864SPL set ID 21fa26f2-0162-4044-aec0-d5360be3f3e0RxCUI 1535362, 2121950UNII 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

N425047077216 followed by a unit qualifier and the quantity

Package 25047-0772-16. 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 topical application of fluoride to aid in the protection against dental caries.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 25047-772

What is NDC 25047-772?
25047-772 is the product NDC for Kolorz Sixty Second Fluoride Cherry Cheesecake, Sodium fluoride 12.3 mg/mL gel, 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 Sixty Second Fluoride Cherry Cheesecake (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 Sixty Second Fluoride Cherry Cheesecake?
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.

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