denavir

Generic: penciclovir

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name denavir
Generic Name penciclovir
Labeler mylan pharmaceuticals inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

penciclovir 10 mg/g

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-9720
Product ID 0378-9720_3f576b33-fe11-41ec-b6d2-6ed89b58fbcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020629
Listing Expiration 2026-12-31
Marketing Start 2018-09-24

Pharmacologic Class

Established (EPC)
herpesvirus nucleoside analog dna polymerase inhibitor [epc]
Mechanism of Action
dna polymerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03789720
Hyphenated Format 0378-9720

Supplemental Identifiers

RxCUI
211343 312255
UNII
359HUE8FJC
NUI
N0000020060 N0000175468 N0000175459

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name denavir (source: ndc)
Generic Name penciclovir (source: ndc)
Application Number NDA020629 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0378-9720-55) / 5 g in 1 TUBE
source: ndc

Packages (1)

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

Ingredients (1)

penciclovir (10 mg/g)

Linked Drug Pages (1)

Denavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3f576b33-fe11-41ec-b6d2-6ed89b58fbcb", "openfda": {"nui": ["N0000020060", "N0000175468", "N0000175459"], "unii": ["359HUE8FJC"], "rxcui": ["211343", "312255"], "spl_set_id": ["61229829-55a0-4d6f-a423-4b48a2b4d8e5"], "pharm_class_epc": ["Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0378-9720-55)  / 5 g in 1 TUBE", "package_ndc": "0378-9720-55", "marketing_start_date": "20180924"}], "brand_name": "Denavir", "product_id": "0378-9720_3f576b33-fe11-41ec-b6d2-6ed89b58fbcb", "dosage_form": "CREAM", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "0378-9720", "generic_name": "penciclovir", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Denavir", "active_ingredients": [{"name": "PENCICLOVIR", "strength": "10 mg/g"}], "application_number": "NDA020629", "marketing_category": "NDA", "marketing_start_date": "20180924", "listing_expiration_date": "20261231"}