NDC codes

FDA NDC Directory
Product NDC (as listed)0126-0088Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00126-0088Add 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
0126-0088-0200126008802001260088021 TUBE in 1 CARTON (0126-0088-02) / 56 g in 1 TUBEMarketed from Jul 15, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
PreviDent Fresh Mint
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 5 mg/g
Dosage form
Gel, Dentifrice
Route
Dental
Labeler
Colgate Oral Pharmaceuticals, Inc.NDC labeler code 0126
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 0126-0088_e16a75ef-1e92-474e-8134-f9f3416a07efSPL ID e16a75ef-1e92-474e-8134-f9f3416a07efSPL set ID 2ecc57ec-cd25-4911-9247-6375569b8abeRxCUI 392038, 630194UNII 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 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

N400126008802 followed by a unit qualifier and the quantity

Package 00126-0088-02. 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. 1-4 PreviDent® 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0126-0088

What is NDC 0126-0088?
0126-0088 is the product NDC for PreviDent Fresh Mint (sodium fluoride), Sodium fluoride 5 mg/g gel, dentifrice, listed with the FDA by Colgate Oral Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
PreviDent Fresh Mint (Sodium Fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
Colgate Oral Pharmaceuticals, Inc., NDC labeler code 0126. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for PreviDent Fresh Mint?
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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