LAMICTAL

In shortageOrange BookUNIISPLATC N03AX09

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

Identification

ManufacturerGlaxoSmithKline LLC

CountryUS (United States)

ATC codeN03AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0173077602
1 DOSE PACK in 1 CARTON (0173-0776-02) / 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK

Annotations

UNII (FDA Substance ID)

U3H27498KS

LAMOTRIGINE

RxCUI 28439

Orange Book

N022251

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Lamotrigine Tablet, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "U3H27498KS",
    "rxcui": "28439",
    "inchikey": "PYZRQGJRPPTADH-UHFFFAOYSA-N",
    "display_name": "LAMOTRIGINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "0173-0776_4492fd3c-e068-4599-8a10-0b26ea2a4f91",
  "productndc": "0173-0776",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "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": "LAMOTRIGINE",
  "shortage_reason": "Lamotrigine Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "LAMICTAL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022251",
  "marketing_category": "NDA",
  "nonproprietary_name": "lamotrigine",
  "start_marketing_date": "20090605",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AX09.

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