fycompa

Generic: perampanel

Labeler: catalyst pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fycompa
Generic Name perampanel
Labeler catalyst pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

perampanel 4 mg/1

Manufacturer
Catalyst Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 69616-274
Product ID 69616-274_98f5e818-1e3f-43a8-9a56-9c44e639f431
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202834
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2024-01-02

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 69616274
Hyphenated Format 69616-274

Supplemental Identifiers

RxCUI
1356557 1356563 1356570 1356572 1356574 1356576 1356578 1356580 1356582 1356584 1356586 1356588 1790122 1790126 2641918 2641919
UPC
0369616278303 0369616276309 0369616274305 0369616280306 0369616290381
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 PACKAGE (69616-274-14)
  • 30 TABLET in 1 BOTTLE (69616-274-30)
  • 90 TABLET in 1 BOTTLE (69616-274-90)
source: ndc

Packages (3)

69616-274-14 14 TABLET in 1 PACKAGE (69616-274-14) 69616-274-30 30 TABLET in 1 BOTTLE (69616-274-30) 69616-274-90 90 TABLET in 1 BOTTLE (69616-274-90)

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": "98f5e818-1e3f-43a8-9a56-9c44e639f431", "openfda": {"nui": ["N0000186106", "N0000020016", "N0000191273", "N0000191278", "N0000182141", "N0000187062"], "upc": ["0369616278303", "0369616276309", "0369616274305", "0369616280306", "0369616290381"], "unii": ["H821664NPK"], "rxcui": ["1356557", "1356563", "1356570", "1356572", "1356574", "1356576", "1356578", "1356580", "1356582", "1356584", "1356586", "1356588", "1790122", "1790126", "2641918", "2641919"], "spl_set_id": ["ec812ea3-de3a-4271-957c-db8f692d1ae3"], "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": ["Catalyst Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 TABLET in 1 PACKAGE (69616-274-14)", "package_ndc": "69616-274-14", "marketing_start_date": "20240102"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (69616-274-30)", "package_ndc": "69616-274-30", "marketing_start_date": "20240102"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69616-274-90)", "package_ndc": "69616-274-90", "marketing_start_date": "20240102"}], "brand_name": "Fycompa", "product_id": "69616-274_98f5e818-1e3f-43a8-9a56-9c44e639f431", "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": "69616-274", "dea_schedule": "CIII", "generic_name": "perampanel", "labeler_name": "Catalyst Pharmaceuticals, 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": "20240102", "listing_expiration_date": "20261231"}