Over-the-counter drug · ANDA
Julie Cold Sore Treatment (docosanol) NDC 82791-362
Docosanol 100 mg/g · Cream · Topical · Julie Products Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82791-362-01 | 82791036201 | 2 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 Inc
- 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
N482791036201followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 217090
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cold Sore Treatment Docosanoldocosanol | Docosanol 100 mg/g | CreamTopical | Blistex Inc. | 10157-2124 |
| Amazon Basics Docosanoldocosanol | Docosanol 100 mg/g | CreamTopical | Amazon.com Services LLC | 72288-006 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Aurohealth LLC | 58602-019 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Amerisource Bergen | 46122-800 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | KROGER COMPANY | 30142-286 |