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United States · US · US:44567-501_5d75a4ee-4a82-48d9-809b-eabea28c6e96

Levetiracetam

Orange BookUNIISPLATC N03AX14

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerWG Critical Care, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4456750110
    10 BAG in 1 CARTON (44567-501-10) / 100 mL in 1 BAG (44567-501-01)

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
N202543
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": "44567-501_5d75a4ee-4a82-48d9-809b-eabea28c6e96",
  "productndc": "44567-501",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "202543",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/100ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 9, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 9, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1.5GM/100ML (15MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 9, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "250MG/50ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Dec 14, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA202543",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20200824",
  "active_numerator_strength": "5"
}

Related drugs

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