perampanel

Generic: perampanel

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name perampanel
Generic Name perampanel
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

perampanel 12 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-7068
Product ID 0480-7068_d20021d0-2d19-4e8c-8ddb-9dbc0f6bca40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209801
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-05-29

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 04807068
Hyphenated Format 0480-7068

Supplemental Identifiers

RxCUI
1356557 1356570 1356574 1356578 1356582 1356586
UPC
0304807067564 0304807066567 0304807062569
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 perampanel (source: ndc)
Generic Name perampanel (source: ndc)
Application Number ANDA209801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0480-7068-56)
source: ndc

Packages (1)

0480-7068-56 30 TABLET, FILM COATED in 1 BOTTLE (0480-7068-56)

Ingredients (1)

perampanel (12 mg/1)

Linked Drug Pages (1)

Perampanel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d20021d0-2d19-4e8c-8ddb-9dbc0f6bca40", "openfda": {"nui": ["N0000186106", "N0000020016", "N0000191273", "N0000191278", "N0000182141", "N0000187062"], "upc": ["0304807067564", "0304807066567", "0304807062569"], "unii": ["H821664NPK"], "rxcui": ["1356557", "1356570", "1356574", "1356578", "1356582", "1356586"], "spl_set_id": ["bc8f7cf2-c19c-4235-859f-9ff1dd21908e"], "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": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0480-7068-56)", "package_ndc": "0480-7068-56", "marketing_start_date": "20250529"}], "brand_name": "Perampanel", "product_id": "0480-7068_d20021d0-2d19-4e8c-8ddb-9dbc0f6bca40", "dosage_form": "TABLET, FILM COATED", "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": "0480-7068", "dea_schedule": "CIII", "generic_name": "Perampanel", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Perampanel", "active_ingredients": [{"name": "PERAMPANEL", "strength": "12 mg/1"}], "application_number": "ANDA209801", "marketing_category": "ANDA", "marketing_start_date": "20250529", "listing_expiration_date": "20261231"}