Prescription drug · ANDA
Penciclovir NDC 69238-1791
Penciclovir 10 mg/g · Cream · Topical · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1791-7 | 69238179107 | 1 TUBE in 1 CARTON (69238-1791-7) / 5 g in 1 TUBEMarketed from Aug 25, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Penciclovir
- Generic name (nonproprietary)
- penciclovir
- Active ingredients
- Penciclovir — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214100
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 69238-1791_1ca2d723-c10a-4170-a3e6-7a7f399c72f2SPL ID 1ca2d723-c10a-4170-a3e6-7a7f399c72f2SPL set ID 9118bbe9-8231-40c8-b11a-6c4a5f41aa16RxCUI 312255UNII 359HUE8FJCUPC 0369238179170
- Pharmacologic class
- Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
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
N469238179107followed by a unit qualifier and the quantityPackage 69238-1791-07. 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)
Penciclovir cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. Penciclovir cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older. (1)
Excerpt only. Read the full label for complete information.