Prescription drug · ANDA
Penciclovir NDC 13668-661
Penciclovir 10 mg/g · Cream · Topical · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-661-10 | 13668066110 | 1 TUBE in 1 CARTON (13668-661-10) / 5 g in 1 TUBEMarketed from Aug 7, 2023 |
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)
- 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 216981
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 13668-661_05e9763e-c5f9-4be9-b822-8242a44e76edSPL ID 05e9763e-c5f9-4be9-b822-8242a44e76edSPL set ID dfbd90ed-4135-486a-807b-27c668154b2eRxCUI 312255UNII 359HUE8FJCUPC 0313668661101
- 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
N413668066110followed by a unit qualifier and the quantityPackage 13668-0661-10. 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 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 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.