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United States · US · US:68788-7884_330f748b-2260-4e6d-b48d-4499bf31d561

Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

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

Packs · 5

  • ndc11
    6878878841
    100 TABLET, FILM COATED in 1 BOTTLE (68788-7884-1)
  • ndc11
    6878878842
    20 TABLET, FILM COATED in 1 BOTTLE (68788-7884-2)
  • ndc11
    6878878843
    30 TABLET, FILM COATED in 1 BOTTLE (68788-7884-3)
  • ndc11
    6878878846
    60 TABLET, FILM COATED in 1 BOTTLE (68788-7884-6)
  • ndc11
    6878878849
    90 TABLET, FILM COATED in 1 BOTTLE (68788-7884-9)

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A090515
ABABABAB
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": "68788-7884_330f748b-2260-4e6d-b48d-4499bf31d561",
  "productndc": "68788-7884",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090515",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Oct 8, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "004",
        "approval_date": "Oct 8, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090515",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20210329",
  "active_numerator_strength": "250"
}

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