NDC codes

FDA NDC Directory
Product NDC (as listed)59883-030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59883-0030Add 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
59883-030-0459883003004598830030041 TUBE in 1 BOX (59883-030-04) / 112 g in 1 TUBEMarketed from Jan 6, 2017

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)
Fluoridex
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 5 mg/gPotassium nitrate — 50 mg/g
Dosage form
Paste, Dentifrice
Route
Dental
Labeler
DENT-MAT HOLDINGS, LLC.NDC labeler code 59883
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 59883-030_020d58ac-51bc-19a2-e063-6394a90aedf6SPL ID 020d58ac-51bc-19a2-e063-6394a90aedf6SPL set ID 6050ef4d-50e8-55d7-e053-2991aa0ad076RxCUI 637365, 847014UNII 8ZYQ1474W7, RU45X2JN0Z

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

N459883003004 followed by a unit qualifier and the quantity

Package 59883-0030-04. 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)

Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59883-030

What is NDC 59883-030?
59883-030 is the product NDC for Fluoridex (sodium fluoride), Sodium fluoride 5 mg/g; Potassium nitrate 50 mg/g paste, dentifrice, listed with the FDA by DENT-MAT HOLDINGS, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluoridex (Sodium Fluoride).
What is the active ingredient?
Sodium fluoride, Potassium nitrate.
Who is the labeler?
DENT-MAT HOLDINGS, LLC., NDC labeler code 59883. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluoridex?
4 other product NDCs are listed under this name. See all Fluoridex 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 Fluoridex NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fluoridexsodium fluorideSodium fluoride 5 mg/gPaste, DentifriceDentalDEN-MAT HOLDINGS, LLC.59883-02059883-0020-04
Fluoridexsodium fluorideSodium fluoride 5 mg/gPaste, DentifriceDentalDEN-MAT HOLDINGS, LLC.59883-01659883-0016-04
Fluoridexsodium fluoridePotassium nitrate 50 mg/g; Sodium fluoride 5 mg/gPaste, DentifriceDentalDENT-MAT HOLDINGS, LLC.59883-03159883-0031-0459883-0031-05
Fluoridexstannous fluoride rinseStannous fluoride 1.53 mg/gLiquidOralDEN-MAT HOLDINGS, LLC59883-00459883-0004-01

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