famciclovir

Generic: famciclovir

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famciclovir
Generic Name famciclovir
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famciclovir 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-998
Product ID 63187-998_f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202438
Listing Expiration 2026-12-31
Marketing Start 2014-09-10

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 63187998
Hyphenated Format 63187-998

Supplemental Identifiers

RxCUI
198382
UPC
0363187998219
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 ANDA202438 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 21 TABLET, FILM COATED in 1 BOTTLE (63187-998-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-998-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-998-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-998-90)
source: ndc

Packages (4)

63187-998-21 21 TABLET, FILM COATED in 1 BOTTLE (63187-998-21) 63187-998-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-998-30) 63187-998-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-998-60) 63187-998-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-998-90)

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": "f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000175459"], "upc": ["0363187998219"], "unii": ["QIC03ANI02"], "rxcui": ["198382"], "spl_set_id": ["29b7ea8b-b976-45cb-9006-a27ba797b0fd"], "pharm_class_epc": ["Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (63187-998-21)", "package_ndc": "63187-998-21", "marketing_start_date": "20140910"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-998-30)", "package_ndc": "63187-998-30", "marketing_start_date": "20140910"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-998-60)", "package_ndc": "63187-998-60", "marketing_start_date": "20140910"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-998-90)", "package_ndc": "63187-998-90", "marketing_start_date": "20140910"}], "brand_name": "Famciclovir", "product_id": "63187-998_f77d4f79-bf54-40dd-84c8-8b2cd1c2ebe4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "63187-998", "generic_name": "Famciclovir", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famciclovir", "active_ingredients": [{"name": "FAMCICLOVIR", "strength": "500 mg/1"}], "application_number": "ANDA202438", "marketing_category": "ANDA", "marketing_start_date": "20140910", "listing_expiration_date": "20261231"}