famciclovir

Generic: famciclovir

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famciclovir
Generic Name famciclovir
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famciclovir 500 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3247
Product ID 60505-3247_4c5bca9f-f6ee-57ce-1894-b84a21162b7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091480
Marketing Start 2011-12-20
Marketing End 2026-07-31

Pharmacologic Class

Established (EPC)
herpes simplex virus 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 605053247
Hyphenated Format 60505-3247

Supplemental Identifiers

RxCUI
198382 199192 199193
UNII
QIC03ANI02
NUI
N0000020060 N0000180187 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 famciclovir (source: ndc)
Generic Name famciclovir (source: ndc)
Application Number ANDA091480 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-3247-3)
source: ndc

Packages (1)

Ingredients (1)

famciclovir (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4c5bca9f-f6ee-57ce-1894-b84a21162b7e", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000175459"], "unii": ["QIC03ANI02"], "rxcui": ["198382", "199192", "199193"], "spl_set_id": ["a5c46194-3692-cd26-0d85-6371974ccc44"], "pharm_class_epc": ["Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-3247-3)", "package_ndc": "60505-3247-3", "marketing_end_date": "20260731", "marketing_start_date": "20111220"}], "brand_name": "FAMCICLOVIR", "product_id": "60505-3247_4c5bca9f-f6ee-57ce-1894-b84a21162b7e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "60505-3247", "generic_name": "FAMCICLOVIR", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FAMCICLOVIR", "active_ingredients": [{"name": "FAMCICLOVIR", "strength": "500 mg/1"}], "application_number": "ANDA091480", "marketing_category": "ANDA", "marketing_end_date": "20260731", "marketing_start_date": "20111220"}