What is NDC 57511-0503?

57511-0503 is the product NDC for FluoriMax 5000 Sensitive, Potassium nitrate 5 g/100g; Sodium fluoride 1.1 g/100g paste, dentifrice, listed with the FDA by Elevate Oral Care. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

FluoriMax 5000 Sensitive (1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste).

What is the active ingredient?

Potassium nitrate, Sodium fluoride.

Elevate Oral Care, NDC labeler code 57511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for FluoriMax 5000 Sensitive?

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.

FluoriMax 5000 Sensitive NDC 57511-0503

NDC codes

FDA NDC Directory

Product NDC (as listed)57511-0503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57511-0503Add 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
57511-0503-1	5751105030157511050301	96 g in 1 TUBE (57511-0503-1)Marketed from Aug 31, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): FluoriMax 5000 Sensitive
Generic name (nonproprietary): 1.1% sodium fluoride with 5% potassium nitrate toothpaste
Active ingredients: Potassium nitrate — 5 g/100gSodium fluoride — 1.1 g/100g
Dosage form: Paste, Dentifrice
Route: Topical
Labeler: Elevate Oral CareNDC labeler code 57511
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Aug 31, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 57511-0503_ae32b0a2-e430-6a56-e053-2a95a90a0b00SPL ID ae32b0a2-e430-6a56-e053-2a95a90a0b00SPL set ID ae32b0a2-e42f-6a56-e053-2a95a90a0b00RxCUI 637365, 2603764UNII RU45X2JN0Z, 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N457511050301 followed by a unit qualifier and the quantity

Package 57511-0503-01. 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 Aug 31, 2020.

Full label on DailyMed (opens in a new tab)

About NDC 57511-0503

What is NDC 57511-0503?: 57511-0503 is the product NDC for FluoriMax 5000 Sensitive, Potassium nitrate 5 g/100g; Sodium fluoride 1.1 g/100g paste, dentifrice, listed with the FDA by Elevate Oral Care. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: FluoriMax 5000 Sensitive (1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste).
What is the active ingredient?: Potassium nitrate, Sodium fluoride.
Who is the labeler?: Elevate Oral Care, NDC labeler code 57511. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for FluoriMax 5000 Sensitive?: 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.