penciclovir

Generic: penciclovir

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name penciclovir
Generic Name penciclovir
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

penciclovir 10 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-440
Product ID 45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212368
Listing Expiration 2026-12-31
Marketing Start 2024-11-07

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 45802440
Hyphenated Format 45802-440

Supplemental Identifiers

RxCUI
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 penciclovir (source: ndc)
Generic Name penciclovir (source: ndc)
Application Number ANDA212368 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE
source: ndc

Packages (1)

45802-440-75 1 TUBE in 1 CARTON (45802-440-75) / 5 g in 1 TUBE

Ingredients (1)

penciclovir (10 mg/g)

Linked Drug Pages (1)

PENCICLOVIR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "aa3c82bd-5e27-4b4d-af88-6b80e5779f2c", "openfda": {"nui": ["N0000020060", "N0000175468", "N0000175459"], "unii": ["359HUE8FJC"], "rxcui": ["312255"], "spl_set_id": ["72da67d0-1349-4408-be13-9935bd9c0179"], "pharm_class_epc": ["Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-440-75)  / 5 g in 1 TUBE", "package_ndc": "45802-440-75", "marketing_start_date": "20241107"}], "brand_name": "PENCICLOVIR", "product_id": "45802-440_aa3c82bd-5e27-4b4d-af88-6b80e5779f2c", "dosage_form": "CREAM", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "45802-440", "generic_name": "penciclovir", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PENCICLOVIR", "active_ingredients": [{"name": "PENCICLOVIR", "strength": "10 mg/g"}], "application_number": "ANDA212368", "marketing_category": "ANDA", "marketing_start_date": "20241107", "listing_expiration_date": "20261231"}