NDC codes

FDA NDC Directory
Product NDC (as listed)82791-362Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82791-0362Add 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
82791-362-0182791036201827910362012 g in 1 TUBE (82791-362-01)Marketed from Jul 2, 2024

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)
Julie Cold Sore Treatment
Generic name (nonproprietary)
docosanol
Active ingredients
Docosanol — 100 mg/g
Dosage form
Cream
Route
Topical
Labeler
Julie Products IncNDC labeler code 82791
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217090
Marketing start
Listing expires
Identifiers
Product ID 82791-362_1d9a1236-b360-4be1-e063-6294a90a27d6SPL ID 1d9a1236-b360-4be1-e063-6294a90a27d6SPL set ID 113372a4-58de-f829-e063-6294a90a4eb1RxCUI 797534UNII 9G1OE216XYUPC 0850043801382

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N482791036201 followed by a unit qualifier and the quantity

Package 82791-0362-01. 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82791-362

What is NDC 82791-362?
82791-362 is the product NDC for Julie Cold Sore Treatment (docosanol), Docosanol 100 mg/g cream, listed with the FDA by Julie Products Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Julie Cold Sore Treatment (Docosanol).
What is the active ingredient?
Docosanol.
Who is the labeler?
Julie Products Inc, NDC labeler code 82791. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Julie Cold Sore Treatment?
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.

Other NDCs under ANDA 217090

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217090
ProductStrengthForm · routeLabelerProduct NDC
Amazon Basics DocosanoldocosanolDocosanol 100 mg/gCreamTopicalAmazon.com Services LLC72288-006
Cold Sore Treatment DocosanoldocosanolDocosanol 100 mg/gCreamTopicalBlistex Inc.10157-2124
DocosanolDocosanol 100 mg/gCreamTopicalKROGER COMPANY30142-286
DocosanolDocosanol 100 mg/gCreamTopicalAmerisource Bergen46122-800
DocosanolDocosanol 100 mg/gCreamTopicalAurohealth LLC58602-019

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