famciclovir

Generic: famciclovir

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famciclovir
Generic Name famciclovir
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famciclovir 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-168
Product ID 55289-168_4199c092-c45c-3922-e063-6294a90aadb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077487
Listing Expiration 2026-12-31
Marketing Start 2007-09-05

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 55289168
Hyphenated Format 55289-168

Supplemental Identifiers

RxCUI
198382
UPC
0355289168034
UNII
QIC03ANI02
NUI
N0000020060 N0000180187 N0000175459

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 ANDA077487 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03)
source: ndc

Packages (1)

55289-168-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03)

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": "4199c092-c45c-3922-e063-6294a90aadb7", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000175459"], "upc": ["0355289168034"], "unii": ["QIC03ANI02"], "rxcui": ["198382"], "spl_set_id": ["2c44b8d2-3b70-4e8b-af03-2e917178f761"], "pharm_class_epc": ["Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03)", "package_ndc": "55289-168-03", "marketing_start_date": "20110414"}], "brand_name": "Famciclovir", "product_id": "55289-168_4199c092-c45c-3922-e063-6294a90aadb7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "55289-168", "generic_name": "Famciclovir", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famciclovir", "active_ingredients": [{"name": "FAMCICLOVIR", "strength": "500 mg/1"}], "application_number": "ANDA077487", "marketing_category": "ANDA", "marketing_start_date": "20070905", "listing_expiration_date": "20261231"}