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United States · US · US:63323-400_87d6e0ef-ffd5-49d6-b9df-ef216576d3e8

Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332340044
    10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41)

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A090876
AP
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": "63323-400_87d6e0ef-ffd5-49d6-b9df-ef216576d3e8",
  "productndc": "63323-400",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "090876",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/5ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 13, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090876",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVETIRACETAM",
  "start_marketing_date": "20150813",
  "active_numerator_strength": "100"
}

Related drugs

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