Denavir (penciclovir) NDC 0378-9720

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-9720Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-9720Add 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 NDC	11-digit (billing)	Package	Copy
0378-9720-55	00378972055	1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBEMarketed from Sep 24, 2018

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): Denavir
Generic name (nonproprietary): penciclovir
Active ingredients: Penciclovir — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020629
Marketing start: Sep 24, 2018
Listing expires: Dec 31, 2026
Other FDA classes: DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
Identifiers: Product ID 0378-9720_3f576b33-fe11-41ec-b6d2-6ed89b58fbcbSPL ID 3f576b33-fe11-41ec-b6d2-6ed89b58fbcbSPL set ID 61229829-55a0-4d6f-a423-4b48a2b4d8e5RxCUI 211343, 312255UNII 359HUE8FJC
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

N400378972055 followed by a unit qualifier and the quantity

Package 00378-9720-55. 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 Nov 26, 2018.

Indications (excerpt from the label)

DENAVIR 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. DENAVIR ® is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients12 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020629

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

FDA NDC Directory listings under NDA 020629
Product	Strength	Form · route	Labeler	Product NDC
Penciclovir	Penciclovir 10 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-0896