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United States · US · US:70752-203_339d66da-457a-4267-806b-7673122db283

LEVETIRACETAM

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerQUAGEN PHARMACEUTICALS LLC
CountryUS (United States)
ATC codeN03AX14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7075220302
    10 CUP, UNIT-DOSE in 1 TRAY (70752-203-02) / 15 mL in 1 CUP, UNIT-DOSE
  • ndc11
    7075220312
    473 mL in 1 BOTTLE (70752-203-12)
  • ndc11
    7075220316
    10 CUP, UNIT-DOSE in 1 TRAY (70752-203-16) / 5 mL in 1 CUP, UNIT-DOSE
  • ndc11
    7075220327
    10 CUP, UNIT-DOSE in 1 TRAY (70752-203-27) / 10 mL in 1 CUP, UNIT-DOSE

Annotations

UNII (FDA Substance ID)
44YRR34555
LEVETIRACETAM
RxCUI 114477
Orange Book
A090079
AA
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": "70752-203_339d66da-457a-4267-806b-7673122db283",
  "productndc": "70752-203",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "090079",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Apr 11, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "LEVETIRACETAM",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090079",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LEVETIRACETAM",
  "start_marketing_date": "20250201",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX14.

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