Levetiracetam in Sodium Chloride

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143928210
10 BAG in 1 BOX (0143-9282-10) / 100 mL in 1 BAG (0143-9282-01)

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

A211356

APAPAP

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": "INTRAVENOUS",
  "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": "0143-9282_f3105bfa-50ba-4e2f-8eae-0313242d8dcf",
  "productndc": "0143-9282",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "211356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/100ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1GM/100ML (10MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.5GM/100ML (15MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "Levetiracetam in Sodium Chloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA211356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levetiracetam in Sodium Chloride",
  "start_marketing_date": "20250208",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N03AX14.

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