NDC codes

FDA NDC Directory
Product NDC (as listed)57511-0005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57511-0005Add 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
57511-0005-1575110005012 TUBE in 1 BOX (57511-0005-1) / 1 g in 1 TUBEMarketed from May 31, 2022

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)
Allday 5000
Generic name (nonproprietary)
1.1% sodium fluoride toothpaste
Active ingredients
Sodium 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
Listing expires
Identifiers
Product ID 57511-0005_3f7aeab7-532f-4ea4-e063-6294a90a6e76SPL ID 3f7aeab7-532f-4ea4-e063-6294a90a6e76SPL set ID d92b84db-2202-33cc-e053-2a95a90a1753RxCUI 392038, 2602147UNII 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

N457511000501 followed by a unit qualifier and the quantity

Package 57511-0005-01. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 57511-0005

What is NDC 57511-0005?
57511-0005 is the product NDC for Allday 5000 (1.1% sodium fluoride toothpaste), 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?
Allday 5000 (1.1% Sodium Fluoride Toothpaste).
What is the active ingredient?
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 Allday 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.

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