Prescription drug · UNAPPROVED DRUG OTHER
Just Right 5000 (1.1% sodium fluoride toothpaste) NDC 57511-0001
Sodium fluoride 1.1 g/100g · Gel, Dentifrice · Topical · Elevate Oral Care
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57511-0001-1 | 5751100010157511000101 | 97 g in 1 TUBE (57511-0001-1)Marketed from Aug 5, 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)
- Just Right 5000
- Generic name (nonproprietary)
- 1.1% sodium fluoride toothpaste
- Active ingredients
- Sodium fluoride — 1.1 g/100g
- Dosage form
- Gel, 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 57511-0001_3f2cd573-ebed-738b-e063-6294a90a1f87SPL ID 3f2cd573-ebed-738b-e063-6294a90a1f87SPL set ID ac24342d-382e-6fc2-e053-2a95a90acd69RxCUI 392038UNII 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
N457511000101followed by a unit qualifier and the quantityPackage 57511-0001-01. 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 .
About NDC 57511-0001
- What is NDC 57511-0001?
- 57511-0001 is the product NDC for Just Right 5000 (1.1% sodium fluoride toothpaste), Sodium fluoride 1.1 g/100g gel, 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?
- Just Right 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 Just Right 5000?
- 2 other product NDCs are listed under this name. See all Just Right 5000 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Just Right 5000 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Just Right 50001.1% sodium fluoride toothpaste | Sodium fluoride 1.1 g/100g | Gel, DentifriceTopical | Elevate Oral Care | 57511-0002 | 57511-0002-01 |
| Just Right 50001.1% sodium fluoride toothpaste | Sodium fluoride 1.1 g/100g | Gel, DentifriceTopical | Elevate Oral Care | 57511-0003 | 57511-0003-01 |