Lamotrigine Extended Release

In shortageOrange BookUNIISPLATC N03AX09

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

Identification

ManufacturerPar Health USA, LLC

CountryUS (United States)

ATC codeN03AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4988460411
30 TABLET in 1 BOTTLE (49884-604-11)

Annotations

UNII (FDA Substance ID)

U3H27498KS

LAMOTRIGINE

RxCUI 28439

Orange Book

A201791

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": "49884-604_9c5e0c2a-800e-47e9-a26b-582b98a05957",
  "productndc": "49884-604",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201791",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jan 18, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Jan 18, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jan 18, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "005",
        "approval_date": "Jan 18, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "006",
        "approval_date": "Jan 18, 2013"
      }
    ],
    "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 Extended Release",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201791",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lamotrigine extended release",
  "start_marketing_date": "20130118",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code N03AX09.

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