fycompa

Generic: perampanel

Labeler: eisai inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fycompa
Generic Name perampanel
Labeler eisai inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

perampanel 4 mg/1

Manufacturer
Eisai Inc.

Identifiers & Regulatory

Product NDC 62856-274
Product ID 62856-274_57623abc-0527-46c7-9046-4e4d077edbad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202834
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2012-10-22

Pharmacologic Class

Established (EPC)
noncompetitive ampa glutamate receptor antagonist [epc]
Mechanism of Action
ampa receptor antagonists [moa] ugt2b7 inhibitors [moa] ugt1a9 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c8 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62856274
Hyphenated Format 62856-274

Supplemental Identifiers

RxCUI
1356557 1356563 1356570 1356572 1356574 1356576 1356578 1356580 1356582 1356584 1356586 1356588 1790122 1790126
UPC
0362856278300 0362856243902 0362856274302 0362856272308 0362856276306 0362856282307 0362856280303
UNII
H821664NPK
NUI
N0000186106 N0000020016 N0000191273 N0000191278 N0000182141 N0000187062

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 fycompa (source: ndc)
Generic Name perampanel (source: ndc)
Application Number NDA202834 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 14 TABLET in 1 PACKET (62856-274-14)
  • 30 TABLET in 1 BOTTLE (62856-274-30)
  • 90 TABLET in 1 BOTTLE (62856-274-90)
source: ndc

Packages (3)

62856-274-14 14 TABLET in 1 PACKET (62856-274-14) 62856-274-30 30 TABLET in 1 BOTTLE (62856-274-30) 62856-274-90 90 TABLET in 1 BOTTLE (62856-274-90)

Ingredients (1)

perampanel (4 mg/1)

Linked Drug Pages (1)

Fycompa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "57623abc-0527-46c7-9046-4e4d077edbad", "openfda": {"nui": ["N0000186106", "N0000020016", "N0000191273", "N0000191278", "N0000182141", "N0000187062"], "upc": ["0362856278300", "0362856243902", "0362856274302", "0362856272308", "0362856276306", "0362856282307", "0362856280303"], "unii": ["H821664NPK"], "rxcui": ["1356557", "1356563", "1356570", "1356572", "1356574", "1356576", "1356578", "1356580", "1356582", "1356584", "1356586", "1356588", "1790122", "1790126"], "spl_set_id": ["71cf3309-e182-473c-8b0b-280cabd0e122"], "pharm_class_epc": ["Noncompetitive AMPA Glutamate Receptor Antagonist [EPC]"], "pharm_class_moa": ["AMPA Receptor Antagonists [MoA]", "UGT2B7 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]"], "manufacturer_name": ["Eisai Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 TABLET in 1 PACKET (62856-274-14)", "package_ndc": "62856-274-14", "marketing_start_date": "20180808"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62856-274-30)", "package_ndc": "62856-274-30", "marketing_start_date": "20121022"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62856-274-90)", "package_ndc": "62856-274-90", "marketing_start_date": "20121022"}], "brand_name": "Fycompa", "product_id": "62856-274_57623abc-0527-46c7-9046-4e4d077edbad", "dosage_form": "TABLET", "pharm_class": ["AMPA Receptor Antagonists [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Noncompetitive AMPA Glutamate Receptor Antagonist [EPC]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]"], "product_ndc": "62856-274", "dea_schedule": "CIII", "generic_name": "perampanel", "labeler_name": "Eisai Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fycompa", "active_ingredients": [{"name": "PERAMPANEL", "strength": "4 mg/1"}], "application_number": "NDA202834", "marketing_category": "NDA", "marketing_start_date": "20121022", "listing_expiration_date": "20271231"}