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United States · US · US:72572-360_2688af36-2f4b-499d-95a4-380f2e0d9787

Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerCivica, Inc.
CountryUS (United States)
ATC codeN03AX14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7257236025
    25 VIAL in 1 CARTON (72572-360-25) / 5 mL in 1 VIAL (72572-360-01)

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A090981
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": "72572-360_2688af36-2f4b-499d-95a4-380f2e0d9787",
  "productndc": "72572-360",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "090981",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/5ML (100MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 13, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090981",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20221201",
  "active_numerator_strength": "100"
}

Related drugs

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