What is NDC 69367-310?

69367-310 is the product NDC for Sodium Fluoride 1.1% Gel (sodium fluoride), Sodium fluoride 5 mg/g gel, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Sodium Fluoride 1.1% Gel (Sodium Fluoride).

Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 1.1% 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.

Sodium Fluoride 1.1% Gel NDC 69367-310

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0310Add 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
69367-310-56	69367031056	1 TUBE in 1 CARTON (69367-310-56) / 56 g in 1 TUBEMarketed from Mar 9, 2021

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 1.1% Gel
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 5 mg/g
Dosage form: Gel
Route: Dental
Labeler: Westminster Pharmaceuticals, LLCNDC labeler code 69367
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Mar 9, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 69367-310_d90dff78-94ae-4d62-8283-a30652b7c16cSPL ID d90dff78-94ae-4d62-8283-a30652b7c16c

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

N469367031056 followed by a unit qualifier and the quantity

Package 69367-0310-56. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 69367-310

What is NDC 69367-310?: 69367-310 is the product NDC for Sodium Fluoride 1.1% Gel (sodium fluoride), Sodium fluoride 5 mg/g gel, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sodium Fluoride 1.1% Gel (Sodium Fluoride).
What is the active ingredient?: Sodium fluoride.
Who is the labeler?: Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 1.1% 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.

Sodium Fluoride 1.1% Gel (Sodium fluoride) NDC 69367-310