Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808488201
100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-882-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-882-11)

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

A078993

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": "68084-882_2737b5f9-5127-8b84-e063-6294a90aa140",
  "productndc": "68084-882",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078993",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Jan 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "003",
        "approval_date": "Jan 15, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "004",
        "approval_date": "Jan 15, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078993",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20150501",
  "active_numerator_strength": "750"
}

Related drugs

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