Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerHp Halden Pharma AS

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6629804471
24 BAG in 1 CARTON (66298-0447-1) / 100 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

A208619

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "44YRR34555",
    "rxcui": "114477",
    "inchikey": "HPHUVLMMVZITSG-LURJTMIESA-N",
    "display_name": "LEVETIRACETAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52fa0eec-3dd9-59ca-e063-6394a90a9791": {
      "match": "brand_token",
      "title": "LEVETIRACETAM TABLET, FILM COATED [INJECTA MEDCIAL LLC]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "66298-0447_4420fb70-8e1b-709c-e063-6394a90a1e7a",
  "productndc": "66298-0447",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "208619",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/100ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 31, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.5GM/100ML (15MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 31, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA208619",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVETIRACETAM",
  "start_marketing_date": "20251212",
  "active_numerator_strength": "10"
}

Related drugs

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