Lamotrigine

Orange BookSPL

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

Identification

ManufacturerPar Health USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4988488099
1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-880-99) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A204158

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "49884-880_983458ba-0e97-42af-952c-3662407dde00",
  "productndc": "49884-880",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204158",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 27, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Oct 27, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Oct 27, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Oct 27, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Lamotrigine",
  "active_ingred_unit": null,
  "application_number": "ANDA204158",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamotrigine",
  "start_marketing_date": "20151127",
  "active_numerator_strength": null
}

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