Perampanel

Orange BookUNIISPLATC N03AX22

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN03AX22

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480706356
30 TABLET, FILM COATED in 1 BOTTLE (0480-7063-56)

Annotations

UNII (FDA Substance ID)

H821664NPK

PERAMPANEL

RxCUI 1356552

Orange Book

A209801

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "H821664NPK",
    "rxcui": "1356552",
    "inchikey": "PRMWGUBFXWROHD-UHFFFAOYSA-N",
    "display_name": "PERAMPANEL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4d8be129-f3cb-49ad-ae5a-a74a50dff689": {
      "match": "brand_token",
      "title": "PERAMPANEL SUSPENSION [NOVADOZ PHARMACEUTICALS LLC]",
      "spl_version": "1",
      "published_date": "2025-12-22"
    }
  },
  "productid": "0480-7063_d20021d0-2d19-4e8c-8ddb-9dbc0f6bca40",
  "productndc": "0480-7063",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209801",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "003",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "004",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "005",
        "approval_date": "May 23, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "006",
        "approval_date": "May 23, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PERAMPANEL",
  "proprietary_name": "Perampanel",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209801",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Perampanel",
  "start_marketing_date": "20250529",
  "active_numerator_strength": "4"
}

Related drugs

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