What is NDC 63783-501?

63783-501 is the product NDC for Neutramaxx 5000 Tcp (sodium fluoride), Sodium fluoride 1.1 g/112g paste, dentifrice, listed with the FDA by Massco Dental A Division of Dunagin Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Neutramaxx 5000 Tcp (Sodium fluoride).

Massco Dental A Division of Dunagin Pharmaceuticals, NDC labeler code 63783. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Neutramaxx 5000 Tcp?

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.

Neutramaxx 5000 Tcp NDC 63783-501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63783-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63783-0501Add 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 NDC	11-digit (billing)	Package	Copy
63783-501-04	6378305010463783050104	112 g in 1 TUBE (63783-501-04)Marketed from Aug 1, 2011

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): Neutramaxx 5000 Tcp
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 1.1 g/112g
Dosage form: Paste, Dentifrice
Route: Oral
Labeler: Massco Dental A Division of Dunagin PharmaceuticalsNDC labeler code 63783
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Aug 1, 2011
Listing expires: Dec 31, 2026
Identifiers: Product ID 63783-501_22fb5942-a2d6-4f0e-8064-a6012e05f43bSPL ID 22fb5942-a2d6-4f0e-8064-a6012e05f43bSPL set ID f47cb584-eb8a-4297-ba32-5f435e85aacbRxCUI 392038, 1191716UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463783050104 followed by a unit qualifier and the quantity

Package 63783-0501-04. 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 Dec 17, 2023.

Indications (excerpt from the label)

Indications and Usage Section NeutraMaxxtm 5000 with Tri-Calcium Phosphate is a self applied dentifrice for prevention of tooth decay, orthodontic decalcification and hypersensitivity

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63783-501

What is NDC 63783-501?: 63783-501 is the product NDC for Neutramaxx 5000 Tcp (sodium fluoride), Sodium fluoride 1.1 g/112g paste, dentifrice, listed with the FDA by Massco Dental A Division of Dunagin Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Neutramaxx 5000 Tcp (Sodium fluoride).
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: Massco Dental A Division of Dunagin Pharmaceuticals, NDC labeler code 63783. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neutramaxx 5000 Tcp?: 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.

Neutramaxx 5000 Tcp (Sodium fluoride) NDC 63783-501