famciclovir

Generic: famciclovir

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famciclovir
Generic Name famciclovir
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famciclovir 125 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-414
Product ID 42291-414_485cfe40-2ff0-e83f-e063-6394a90a221c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077487
Listing Expiration 2027-12-31
Marketing Start 2021-05-19

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 42291414
Hyphenated Format 42291-414

Supplemental Identifiers

RxCUI
198382 199192 199193
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
  • 125 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42291-414-30)
source: ndc

Packages (1)

42291-414-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-414-30)

Ingredients (1)

famciclovir (125 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": "485cfe40-2ff0-e83f-e063-6394a90a221c", "openfda": {"nui": ["N0000020060", "N0000180187", "N0000175459"], "unii": ["QIC03ANI02"], "rxcui": ["198382", "199192", "199193"], "spl_set_id": ["c2b21ad5-fa83-1fb6-e053-2a95a90a3d0f"], "pharm_class_epc": ["Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"], "pharm_class_moa": ["DNA Polymerase Inhibitors [MoA]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-414-30)", "package_ndc": "42291-414-30", "marketing_start_date": "20210519"}], "brand_name": "Famciclovir", "product_id": "42291-414_485cfe40-2ff0-e83f-e063-6394a90a221c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "42291-414", "generic_name": "Famciclovir", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famciclovir", "active_ingredients": [{"name": "FAMCICLOVIR", "strength": "125 mg/1"}], "application_number": "ANDA077487", "marketing_category": "ANDA", "marketing_start_date": "20210519", "listing_expiration_date": "20271231"}