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
0173076000
1 BLISTER PACK in 1 PACKAGE, COMBINATION (0173-0760-00) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N022115

ABABABABABAB

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": "0173-0760_0c7b21d8-3c32-4c65-95cd-cada0421d8e3",
  "productndc": "0173-0760",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022115",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "May 29, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "005",
        "approval_date": "Apr 14, 2010"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Jun 21, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "LAMICTAL",
  "active_ingred_unit": null,
  "application_number": "NDA022115",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamotrigine",
  "start_marketing_date": "20090706",
  "active_numerator_strength": null
}

Access this data programmatically

Query LAMICTAL 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