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United States · US · US:0143-9574_14e07144-d548-4e86-ab10-2e16ec58aab7

Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

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

Packs · 2

  • ndc11
    0143957410
    10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)
  • ndc11
    0143957425
    25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01)

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": "0143-9574_14e07144-d548-4e86-ab10-2e16ec58aab7",
  "productndc": "0143-9574",
  "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": "20150601",
  "active_numerator_strength": "100"
}

Related drugs

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