Levetiracetam

Orange BookUNIISPLATC N03AX14

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6699310006
6 BLISTER PACK in 1 CARTON (66993-100-06) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51)
ndc11
6699310060
60 BLISTER PACK in 1 CARTON (66993-100-60) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66993-100-51)

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

N207958

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": "66993-100_265f6517-11c1-4af8-9871-ef7fdde464e6",
  "productndc": "66993-100",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "207958",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jul 31, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Jul 31, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM",
        "product_no": "004",
        "approval_date": "Jul 31, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA207958",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "levetiracetam",
  "start_marketing_date": "20250120",
  "active_numerator_strength": "250"
}

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