Prescription drug · UNAPPROVED DRUG OTHER
Sodium Fluoride Gel (Sodium fluoride) NDC 50268-733
Sodium fluoride 5 mg/g · Gel, Dentifrice · Dental · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-733-56 | 5026807335650268073356 | 1 TUBE in 1 CARTON (50268-733-56) / 56 g in 1 TUBEMarketed from May 9, 2022 |
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)
- Sodium Fluoride Gel
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — 5 mg/g
- Dosage form
- Gel, Dentifrice
- Route
- Dental
- Labeler
- AvPAKNDC labeler code 50268
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 50268-733_47fc8e5e-ba96-0118-e063-6394a90ad45cSPL ID 47fc8e5e-ba96-0118-e063-6394a90ad45cSPL set ID de973f9c-af34-4977-e053-2995a90a54a0UNII 8ZYQ1474W7UPC 0350268733562
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450268073356followed by a unit qualifier and the quantityPackage 50268-0733-56. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. Sodium Fluoride 1.1% Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Excerpt only. Read the full label for complete information.
About NDC 50268-733
- What is NDC 50268-733?
- 50268-733 is the product NDC for Sodium Fluoride Gel (sodium fluoride), Sodium fluoride 5 mg/g gel, dentifrice, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Fluoride Gel (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Fluoride Gel?
- 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.