perampanel

Generic: perampanel

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name perampanel
Generic Name perampanel
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

perampanel 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4208
Product ID 51672-4208_4653e298-d84f-dc92-e063-6294a90a2d75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209538
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2025-11-25

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 516724208
Hyphenated Format 51672-4208

Supplemental Identifiers

RxCUI
1356557 1356570 1356574 1356578 1356582 1356586
UPC
0351672420567 0351672420666 0351672420765 0351672420963 0351672420468
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 ANDA209538 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (51672-4208-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4208-6)
source: ndc

Packages (2)

51672-4208-2 3 BLISTER PACK in 1 CARTON (51672-4208-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK 51672-4208-6 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4208-6)

Ingredients (1)

perampanel (10 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": "4653e298-d84f-dc92-e063-6294a90a2d75", "openfda": {"nui": ["N0000186106", "N0000020016", "N0000191273", "N0000191278", "N0000182141", "N0000187062"], "upc": ["0351672420567", "0351672420666", "0351672420765", "0351672420963", "0351672420468"], "unii": ["H821664NPK"], "rxcui": ["1356557", "1356570", "1356574", "1356578", "1356582", "1356586"], "spl_set_id": ["1b0458ea-e718-4d48-ae55-ad9b4d863810"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51672-4208-2)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51672-4208-2", "marketing_start_date": "20251125"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4208-6)", "package_ndc": "51672-4208-6", "marketing_start_date": "20251125"}], "brand_name": "Perampanel", "product_id": "51672-4208_4653e298-d84f-dc92-e063-6294a90a2d75", "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": "51672-4208", "dea_schedule": "CIII", "generic_name": "Perampanel", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Perampanel", "active_ingredients": [{"name": "PERAMPANEL", "strength": "10 mg/1"}], "application_number": "ANDA209538", "marketing_category": "ANDA", "marketing_start_date": "20251125", "listing_expiration_date": "20261231"}