penciclovir

Generic: penciclovir

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name penciclovir
Generic Name penciclovir
Labeler amneal pharmaceuticals ny llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

penciclovir 10 mg/g

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1791
Product ID 69238-1791_1ca2d723-c10a-4170-a3e6-7a7f399c72f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214100
Listing Expiration 2026-12-31
Marketing Start 2025-08-25

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 692381791
Hyphenated Format 69238-1791

Supplemental Identifiers

RxCUI
312255
UPC
0369238179170
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 ANDA214100 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69238-1791-7) / 5 g in 1 TUBE
source: ndc

Packages (1)

69238-1791-7 1 TUBE in 1 CARTON (69238-1791-7) / 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": "1ca2d723-c10a-4170-a3e6-7a7f399c72f2", "openfda": {"nui": ["N0000020060", "N0000175468", "N0000175459"], "upc": ["0369238179170"], "unii": ["359HUE8FJC"], "rxcui": ["312255"], "spl_set_id": ["9118bbe9-8231-40c8-b11a-6c4a5f41aa16"], "pharm_class_epc": ["Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69238-1791-7)  / 5 g in 1 TUBE", "package_ndc": "69238-1791-7", "marketing_start_date": "20250825"}], "brand_name": "Penciclovir", "product_id": "69238-1791_1ca2d723-c10a-4170-a3e6-7a7f399c72f2", "dosage_form": "CREAM", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "69238-1791", "generic_name": "Penciclovir", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Penciclovir", "active_ingredients": [{"name": "PENCICLOVIR", "strength": "10 mg/g"}], "application_number": "ANDA214100", "marketing_category": "ANDA", "marketing_start_date": "20250825", "listing_expiration_date": "20261231"}