LAMICTAL

Orange BookSPL

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

Identification

ManufacturerGlaxoSmithKline LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0173081728
1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0817-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N020241

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "d7e3572d-56fe-4727-2bb4-013ccca22678": {
      "match": "brand_token",
      "title": "LAMICTAL (LAMOTRIGINE) TABLET LAMICTAL (LAMOTRIGINE) TABLET, FOR SUSPENSION LAMICTAL ODT (LAMOTRIGINE) TABLET, ORALLY DISINTEGRATING LAMICTAL (LAMOTRIGINE) KIT [GLAXOSMITHKLINE LLC]",
      "spl_version": "44",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0173-0817_4492fd3c-e068-4599-8a10-0b26ea2a4f91",
  "productndc": "0173-0817",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "020241",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 27, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "002",
        "approval_date": "Dec 27, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Dec 27, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Dec 27, 1994"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "005",
        "approval_date": "Dec 27, 1994"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "006",
        "approval_date": "Dec 27, 1994"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LAMICTAL",
  "active_ingred_unit": null,
  "application_number": "NDA020241",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamotrigine",
  "start_marketing_date": "20030929",
  "active_numerator_strength": null
}

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