Perampanel

Orange BookUNIISPLATC N03AX22

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN03AX22

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5167242062
3 BLISTER PACK in 1 CARTON (51672-4206-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5167242066
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4206-6)

Annotations

UNII (FDA Substance ID)

H821664NPK

PERAMPANEL

RxCUI 1356552

Orange Book

A209538

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": "51672-4206_4653e298-d84f-dc92-e063-6294a90a2d75",
  "productndc": "51672-4206",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209538",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Nov 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "002",
        "approval_date": "Nov 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "003",
        "approval_date": "Nov 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "004",
        "approval_date": "Nov 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "005",
        "approval_date": "Nov 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "006",
        "approval_date": "Nov 25, 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": "ANDA209538",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Perampanel",
  "start_marketing_date": "20251125",
  "active_numerator_strength": "6"
}

Related drugs

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