NDC 40076-624

Denavir

Penciclovir

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

• Product ID: 40076-624_4a971a41-c59b-497a-9498-8c3f3e0d8a6a
• NDC: 40076-624
• Product Type: Human Prescription Drug
• Proprietary Name: Denavir
• Generic Name: Penciclovir
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-10-23
• Marketing End Date: 2020-02-29
• Marketing Category: NDA / NDA
• Application Number: NDA020629
• Labeler Name: Prestium Pharma, 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

Packaging

NDC 40076-624-05

1 TUBE in 1 CARTON (40076-624-05) > 5 g in 1 TUBE

• Marketing Start Date: 2012-10-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 40076-624-05 [40076062405]

Denavir CREAM

• Marketing Category: NDA
• Application Number: NDA020629
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2012-10-23
• Marketing End Date: 2020-02-29

NDC 40076-624-01 [40076062401]

Denavir CREAM

• Marketing Category: NDA
• Application Number: NDA020629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-10-23
• Marketing End Date: 2019-08-31

Drug Details

Active Ingredients

Ingredient	Strength
PENCICLOVIR	10 mg/g

OpenFDA Data

• SPL SET ID: 14d60b68-e5dd-475a-8517-576eb7894683
• Manufacturer:
  • Prestium Pharma, Inc.
• UNII:
  • 359HUE8FJC
• RxNorm Concept Unique ID - RxCUI:
  • 312255
  • 211343
• UPC Code:
  • 0340076624053

Pharmacological Class

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

Medicade Reported Pricing

40076062405 DENAVIR 1% CREAM

Pricing Unit: GM | Drug Type:

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