NDC codes

FDA NDC Directory
Product NDC (as listed)53045-202Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53045-0202Add 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
53045-202-1753045020217490 g in 1 BOTTLE (53045-202-17)Marketed from Jan 1, 2013

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)
Ionite APF
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride6.027 g/490g
Dosage form
Gel
Route
Dental, Oral
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 53045-202_82c5c7de-3c8d-4d31-9d98-32b196abe517SPL ID 82c5c7de-3c8d-4d31-9d98-32b196abe517SPL set ID b8b7f9b8-ff11-4a76-ab36-7822c15e1892RxCUI 1535362UNII 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

N453045020217 followed by a unit qualifier and the quantity

Package 53045-0202-17. 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 .

Full label on DailyMed (opens in a new tab)

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