What is NDC 63783-504?

63783-504 is the product NDC for Neutra Maxx 5000 (sodium fluoride), Sodium fluoride 1.428 g/120g gel, 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?

Neutra Maxx 5000 (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 Neutra Maxx 5000?

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.

Neutra Maxx 5000 NDC 63783-504 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63783-504Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63783-0504Add 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
63783-504-06	6378305040663783050406	120 g in 1 BOTTLE, DISPENSING (63783-504-06)Marketed from Jan 1, 1989

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): Neutra Maxx 5000
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 1.428 g/120g
Dosage form: Gel
Route: Oral
Labeler: Massco Dental A Division of Dunagin PharmaceuticalsNDC labeler code 63783
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 1, 1989
Listing expires: Dec 31, 2026
Identifiers: Product ID 63783-504_cb8064d7-2d0f-4860-b794-d90a121761adSPL ID cb8064d7-2d0f-4860-b794-d90a121761adSPL set ID fcbe6baa-2827-49df-9316-42cc86595203RxCUI 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

N463783050406 followed by a unit qualifier and the quantity

Package 63783-0504-06. 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)

DIRECTIONS DIRECTIONS: (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL) ADULTS AND CHILDREN 6 YEARS AND OLDER: USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE. AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE. BEFORE BEDTIME IS BEST. ADULTS SHOULD EXPECTORATE AFTER USE. CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63783-504

What is NDC 63783-504?: 63783-504 is the product NDC for Neutra Maxx 5000 (sodium fluoride), Sodium fluoride 1.428 g/120g gel, 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?: Neutra Maxx 5000 (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 Neutra Maxx 5000?: 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.

Neutra Maxx 5000 (Sodium fluoride) NDC 63783-504