NDC codes

FDA NDC Directory
Product NDC (as listed)68400-206Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68400-0206Add 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
68400-206-1068400020610283.5 g in 1 BOTTLE, PLASTIC (68400-206-10)Marketed from Jan 1, 2017

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)
Gelato Perio Maintenance Rinse
Generic name (nonproprietary)
stannous fluoride
Active ingredients
Stannous fluoride — .34 g/283.5g
Dosage form
Concentrate
Route
Dental
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 68400-206_16b2ddf9-2d50-cd49-e063-6294a90aa9a4SPL ID 16b2ddf9-2d50-cd49-e063-6294a90aa9a4SPL set ID f8721665-b304-4b1c-9bda-385d7671d099RxCUI 583459, 1435516UNII 3FTR44B32Q

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

N468400020610 followed by a unit qualifier and the quantity

Package 68400-0206-10. 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: Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product must be used under the supervision of a dentist.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68400-206

What is NDC 68400-206?
68400-206 is the product NDC for Gelato Perio Maintenance Rinse (stannous fluoride), Stannous fluoride .34 g/283.5g concentrate, listed with the FDA by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gelato Perio Maintenance Rinse (Stannous Fluoride).
What is the active ingredient?
Stannous fluoride.
Who is the labeler?
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc., NDC labeler code 68400. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gelato Perio Maintenance Rinse?
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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