NDC codes

FDA NDC Directory
Product NDC (as listed)42291-741Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0741Add 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
42291-741-51422910741511 TUBE in 1 CARTON (42291-741-51) / 53.2 mL in 1 TUBEMarketed from Sep 20, 2019

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 Flouride
Generic name (nonproprietary)
sodium fluoride
Active ingredients
Sodium fluoride — 5 mg/mL
Dosage form
Paste, Dentifrice
Route
Dental
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 42291-741_4874ee42-bfbe-02d5-e063-6394a90a2b6eSPL ID 4874ee42-bfbe-02d5-e063-6394a90a2b6eSPL set ID 92fef2e0-f9f2-8b0f-e053-2995a90a096aUNII 8ZYQ1474W7UPC 0342291741515

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

N442291074151 followed by a unit qualifier and the quantity

Package 42291-0741-51. 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 Sodium Fluoride 1.1% in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your 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.

Full label on DailyMed (opens in a new tab)

About NDC 42291-741

What is NDC 42291-741?
42291-741 is the product NDC for Sodium Flouride (sodium fluoride), Sodium fluoride 5 mg/mL paste, dentifrice, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sodium Flouride (Sodium Fluoride).
What is the active ingredient?
Sodium fluoride.
Who is the labeler?
AvKARE, NDC labeler code 42291. 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 Flouride?
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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