famciclovir

Generic: famciclovir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famciclovir
Generic Name famciclovir
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famciclovir 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-467
Product ID 65862-467_c372e46a-af0b-43c2-8f33-d20e4c6e27d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091114
Listing Expiration 2026-12-31
Marketing Start 2011-03-21

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 65862467
Hyphenated Format 65862-467

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 ANDA091114 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-467-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-467-30)
  • 5 BLISTER PACK in 1 CARTON (65862-467-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

65862-467-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-467-05) 65862-467-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-467-30) 65862-467-50 5 BLISTER PACK in 1 CARTON (65862-467-50) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

famciclovir (500 mg/1)

Linked Drug Pages (1)

Famciclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c372e46a-af0b-43c2-8f33-d20e4c6e27d5", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000175459"], "unii": ["QIC03ANI02"], "rxcui": ["198382", "199192", "199193"], "spl_set_id": ["fcf0b0fa-bb2c-4f2c-aa9f-1f2da65d8343"], "pharm_class_epc": ["Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-467-05)", "package_ndc": "65862-467-05", "marketing_start_date": "20110321"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-467-30)", "package_ndc": "65862-467-30", "marketing_start_date": "20110321"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (65862-467-50)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-467-50", "marketing_start_date": "20110321"}], "brand_name": "Famciclovir", "product_id": "65862-467_c372e46a-af0b-43c2-8f33-d20e4c6e27d5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "65862-467", "generic_name": "Famciclovir", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famciclovir", "active_ingredients": [{"name": "FAMCICLOVIR", "strength": "500 mg/1"}], "application_number": "ANDA091114", "marketing_category": "ANDA", "marketing_start_date": "20110321", "listing_expiration_date": "20261231"}