ELEPSIA XR 1000 MG

Orange BookUNIISPLATC N03AX14

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

Identification

ManufacturerTRIPOINT THERAPEUTICS, LLC

CountryUS (United States)

ATC codeN03AX14

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8070510002
1 BLISTER PACK in 1 CARTON (80705-100-02) / 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
8070510030
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80705-100-30)
ndc11
8070510099
1 BLISTER PACK in 1 CARTON (80705-100-99) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

44YRR34555

LEVETIRACETAM

RxCUI 114477

Orange Book

N204417

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": {
    "cac83d47-88a2-4447-a0c0-90b44ffda0ac": {
      "match": "brand_token",
      "title": "ELEPSIA XR 1000 MG (LEVETIRACETAM) TABLET, EXTENDED RELEASE ELEPSIA XR 1500 MG (LEVETIRACETAM) TABLET, EXTENDED RELEASE [TRIPOINT THERAPEUTICS, LLC]",
      "spl_version": "5",
      "published_date": "2024-03-28"
    }
  },
  "productid": "80705-100_3c463bee-1191-4cab-b4d0-367673db19ef",
  "productndc": "80705-100",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204417",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM",
        "product_no": "001",
        "approval_date": "Dec 20, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1.5GM",
        "product_no": "002",
        "approval_date": "Dec 20, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVETIRACETAM",
  "proprietary_name": "ELEPSIA XR 1000 MG",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204417",
  "marketing_category": "NDA",
  "nonproprietary_name": "levetiracetam",
  "start_marketing_date": "20210212",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code N03AX14.

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