Trileptal

Orange BookUNIISPLATC N03AF02

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeN03AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0078045705
100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05)
ndc11
0078045735
100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0457-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0457-61)

Annotations

UNII (FDA Substance ID)

VZI5B1W380

OXCARBAZEPINE

RxCUI 32624

Orange Book

N021014

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "VZI5B1W380",
    "rxcui": "32624",
    "inchikey": "CTRLABGOLIVAIY-UHFFFAOYSA-N",
    "display_name": "OXCARBAZEPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b": {
      "match": "brand_token",
      "title": "TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "39",
      "published_date": "2025-12-18"
    }
  },
  "productid": "0078-0457_dcd739ce-e938-40e6-8912-ca4f34b49cf3",
  "productndc": "0078-0457",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021014",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Jan 14, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "Trileptal",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021014",
  "marketing_category": "NDA",
  "nonproprietary_name": "oxcarbazepine",
  "start_marketing_date": "20000130",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N03AF02.

Access this data programmatically

Query Trileptal and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs