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United States · US · US:68999-548_4357753b-846a-c5ea-e063-6394a90aa1ec

LEVETIRACETAM solution

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeN03AX14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6899954824
    2 TRAY in 1 BOX (68999-548-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-548-45)

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A090263
AA
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": "ORAL",
  "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": "68999-548_4357753b-846a-c5ea-e063-6394a90aa1ec",
  "productndc": "68999-548",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090263",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Apr 3, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "LEVETIRACETAM solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090263",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVETIRACETAM",
  "start_marketing_date": "20090403",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX14.

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