Lamotrigine

In shortageOrange BookUNIISPLATC N03AX09

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeN03AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6846222801
100 TABLET, CHEWABLE in 1 BOTTLE (68462-228-01)
ndc11
6846222810
1000 TABLET, CHEWABLE in 1 BOTTLE (68462-228-10)
ndc11
6846222890
90 TABLET, CHEWABLE in 1 BOTTLE (68462-228-90)

Annotations

UNII (FDA Substance ID)

U3H27498KS

LAMOTRIGINE

RxCUI 28439

Orange Book

A079099

ABAB

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": {
    "68a4dac2-5015-40c5-88ca-204098c3b288": {
      "match": "brand_token",
      "title": "LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68462-228_fc701d94-bfc5-44c4-8667-6414ee7226ed",
  "productndc": "68462-228",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "079099",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 19, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Feb 19, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMOTRIGINE",
  "shortage_reason": "Lamotrigine Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Lamotrigine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079099",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamotrigine",
  "start_marketing_date": "20090219",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N03AX09.

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