Levetiracetam

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6362941371
90 TABLET, FILM COATED in 1 BOTTLE (63629-4137-1)
ndc11
6362941372
60 TABLET, FILM COATED in 1 BOTTLE (63629-4137-2)
ndc11
6362941373
30 TABLET, FILM COATED in 1 BOTTLE (63629-4137-3)
ndc11
6362941374
120 TABLET, FILM COATED in 1 BOTTLE (63629-4137-4)
ndc11
6362941375
28 TABLET, FILM COATED in 1 BOTTLE (63629-4137-5)
ndc11
6362941376
100 TABLET, FILM COATED in 1 BOTTLE (63629-4137-6)
ndc11
6362941377
21 TABLET, FILM COATED in 1 BOTTLE (63629-4137-7)
ndc11
6362941378
180 TABLET, FILM COATED in 1 BOTTLE (63629-4137-8)

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

A078154

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": "63629-4137_505a2d97-ea8d-4e3a-9af7-95df7f59d89b",
  "productndc": "63629-4137",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078154",
    "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": "ANDA078154",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam",
  "start_marketing_date": "20090115",
  "active_numerator_strength": "500"
}

Related drugs

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