NDC 40085-415

Penciclovir

Penciclovir

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

• Product ID: 40085-415_f56d602a-8050-46db-ad36-6f1584f314d1
• NDC: 40085-415
• Product Type: Human Prescription Drug
• Proprietary Name: Penciclovir
• Generic Name: Penciclovir
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-10-01
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020629
• Labeler Name: Renaissance 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
• Listing Certified Through: 2019-12-31

Packaging

NDC 40085-415-05

1 TUBE in 1 CARTON (40085-415-05) > 5 g in 1 TUBE

• Marketing Start Date: 2016-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 40085-415-05 [40085041505]

Penciclovir CREAM

• Marketing Category: NDA authorized generic
• Application Number: NDA020629
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-01
• Marketing End Date: 2019-07-31

Drug Details

Active Ingredients

Ingredient	Strength
PENCICLOVIR	10 mg/g

OpenFDA Data

• SPL SET ID: b7ff970a-546f-4d7e-acdb-0217b7d7439c
• Manufacturer:
  • Renaissance Pharma, Inc.
• UNII:
  • 359HUE8FJC
• RxNorm Concept Unique ID - RxCUI:
  • 312255

Pharmacological Class

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

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

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