LEVETIRACETAM

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerDIRECT RX

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7218919030
30 TABLET, FILM COATED in 1 BOTTLE (72189-190-30)
ndc11
7218919060
60 TABLET, FILM COATED in 1 BOTTLE (72189-190-60)
ndc11
7218919072
120 TABLET, FILM COATED in 1 BOTTLE (72189-190-72)
ndc11
7218919090
90 TABLET, FILM COATED in 1 BOTTLE (72189-190-90)

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": "72189-190_4c4bd407-ac66-f594-e063-6294a90a31fe",
  "productndc": "72189-190",
  "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": "20210607",
  "active_numerator_strength": "250"
}

Related drugs

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