NDC 0378-9720

Denavir

Penciclovir

Denavir is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Penciclovir.

• Product ID: 0378-9720_ed286bc3-dda6-4f75-9338-3eb0987a2a7d
• NDC: 0378-9720
• Product Type: Human Prescription Drug
• Proprietary Name: Denavir
• Generic Name: Penciclovir
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-09-24
• Marketing Category: NDA / NDA
• Application Number: NDA020629
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: PENCICLOVIR
• Active Ingredient Strength: 10 mg/g
• Pharm Classes: DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0378-9720-55

1 TUBE in 1 CARTON (0378-9720-55) > 5 g in 1 TUBE

• Marketing Start Date: 2018-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-9720-55 [00378972055]

Denavir CREAM

• Marketing Category: NDA
• Application Number: NDA020629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-09-24

Drug Details

Active Ingredients

Ingredient	Strength
PENCICLOVIR	10 mg/g

OpenFDA Data

• SPL SET ID: 61229829-55a0-4d6f-a423-4b48a2b4d8e5
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 359HUE8FJC
• RxNorm Concept Unique ID - RxCUI:
  • 312255
  • 211343

Pharmacological Class

• DNA Polymerase Inhibitors [MoA]
• Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• DNA Polymerase Inhibitors [MoA]
• Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Nucleoside Analog [EXT]

NDC Crossover Matching brand name "Denavir" or generic name "Penciclovir"

NDC	Brand Name	Generic Name
0378-9720	Denavir	penciclovir
40076-624	Denavir	penciclovir
0093-3186	Penciclovir	Penciclovir
0378-0896	Penciclovir	penciclovir
40085-415	Penciclovir	penciclovir