LAMOTRIGINE

In shortageOrange BookUNIISPLATC N03AX09

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeN03AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
1366804801
100 TABLET in 1 BOTTLE (13668-048-01)
ndc11
1366804805
500 TABLET in 1 BOTTLE (13668-048-05)
ndc11
1366804816
1600 TABLET in 1 BOTTLE (13668-048-16)
ndc11
1366804830
30 TABLET in 1 BOTTLE (13668-048-30)
ndc11
1366804860
60 TABLET in 1 BOTTLE (13668-048-60)
ndc11
1366804864
90 TABLET in 1 DOSE PACK (13668-048-64)

Annotations

UNII (FDA Substance ID)

U3H27498KS

LAMOTRIGINE

RxCUI 28439

Orange Book

A078947

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": {
    "68a4dac2-5015-40c5-88ca-204098c3b288": {
      "match": "brand_token",
      "title": "LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "13668-048_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2",
  "productndc": "13668-048",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078947",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jan 27, 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": "ANDA078947",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LAMOTRIGINE",
  "start_marketing_date": "20090127",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N03AX09.

Access this data programmatically

Query LAMOTRIGINE 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