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
0173077900
1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0779-00) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N022251

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": "0173-0779_4492fd3c-e068-4599-8a10-0b26ea2a4f91",
  "productndc": "0173-0779",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022251",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 8, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 8, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 8, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "May 8, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LAMICTAL",
  "active_ingred_unit": null,
  "application_number": "NDA022251",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamotrigine",
  "start_marketing_date": "20090605",
  "active_numerator_strength": null
}

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