NDC codes

FDA NDC Directory
Product NDC (as listed)53045-251Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53045-0251Add 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
53045-251-445304502514453045025144126 g in 1 BOTTLE (53045-251-44)Marketed from Apr 22, 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 FoamSuffix: Foam
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 1.5498 g/126g
Dosage form
Aerosol, Foam
Route
Dental, Oral, Topical
Labeler
Dharma Research, inc.NDC labeler code 53045
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 53045-251_5afd6058-8b76-4081-82df-10a4f49614f0SPL ID 5afd6058-8b76-4081-82df-10a4f49614f0SPL set ID 4828b482-486f-4105-bed0-3fe2ddbbddb1RxCUI 831719UNII 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

N453045025144 followed by a unit qualifier and the quantity

Package 53045-0251-44. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 53045-251

What is NDC 53045-251?
53045-251 is the product NDC for Ionite APF Foam (sodium fluoride), Sodium fluoride 1.5498 g/126g aerosol, foam, listed with the FDA by Dharma Research, inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ionite APF Foam (Sodium Fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
Dharma Research, inc., NDC labeler code 53045. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ionite APF Foam?
3 other product NDCs are listed under this name. See all Ionite APF Foam NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ionite APF Foam NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ionite APF Foamsodium fluorideSodium fluoride 1.5498 g/126gAerosol, FoamDental, Oral, TopicalDharma Research, Inc.53045-25053045-0250-44
Ionite APF Foamsodium fluorideSodium fluoride 1.5498 g/126gAerosol, FoamDental, Oral, TopicalDharma Research, inc.53045-25253045-0252-44
Ionite APF Foamsodium fluorideSodium fluoride 1.5498 g/126gAerosol, FoamDental, Oral, TopicalDharma Research, inc.53045-25353045-0253-44

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