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United States · US · US:55111-183_2de4ebba-b125-4355-35f5-69b92e56634b

Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeN03AX14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    5511118301
    100 TABLET in 1 BOTTLE (55111-183-01)
  • ndc11
    5511118304
    120 TABLET in 1 BOTTLE (55111-183-04)
  • ndc11
    5511118305
    500 TABLET in 1 BOTTLE (55111-183-05)
  • ndc11
    5511118330
    30 TABLET in 1 BOTTLE (55111-183-30)
  • ndc11
    5511118379
    1 BLISTER PACK in 1 CARTON (55111-183-79) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A076920
ABABAB
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": "55111-183_2de4ebba-b125-4355-35f5-69b92e56634b",
  "productndc": "55111-183",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076920",
    "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"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076920",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20090115",
  "active_numerator_strength": "750"
}

Related drugs

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