Avant (sodium fluoride) NDC 53045-268

NDC codes

FDA NDC Directory

Product NDC (as listed)53045-268Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53045-0268Add 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
53045-268-64	53045026864	1.9 L in 1 BOTTLE, PUMP (53045-268-64)Marketed from Jan 22, 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): Avant
Generic name (nonproprietary): sodium fluoride
Active ingredients: Sodium fluoride — 2 g/L
Dosage form: Liquid
Route: Dental
Labeler: Dharma Research, Inc.
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 22, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 53045-268_78538c89-5afb-4316-a86a-1e5237d543e9SPL ID 78538c89-5afb-4316-a86a-1e5237d543e9SPL set ID 4749dce1-c0b9-4737-8a30-85cd58aba21bRxCUI 251960UNII 8ZYQ1474W7UPC 0353045004398

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

N453045026864 followed by a unit qualifier and the quantity

Package 53045-0268-64. 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 Jan 25, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)