Prescription drug · ANDA
Penciclovir NDC 0093-3186
Penciclovir 10 mg/g · Cream · Topical · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3186-20 | 00093318620 | 1 TUBE in 1 CARTON (0093-3186-20) / 5 g in 1 TUBEMarketed from Nov 14, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 212710
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0093-3186_e6116cf2-000d-461f-a8cb-47f4c4ec8d34SPL ID e6116cf2-000d-461f-a8cb-47f4c4ec8d34SPL set ID 5d95b934-2ba6-41b9-928f-6d2ce12f93f5RxCUI 312255UNII 359HUE8FJCUPC 0300933186209
- 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
N400093318620followed by a unit qualifier and the quantityPackage 00093-3186-20. 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.