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United States · US · US:13668-266_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2

LAMOTRIGINE

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTorrent Pharmaceuticals Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1366826628
    14 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-28) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1366826699
    7 BLISTER PACK in 1 PACKAGE, COMBINATION (13668-266-99) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A078947
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": "13668-266_e20d1c8d-dadf-4a54-8f0c-4ce62087f2e2",
  "productndc": "13668-266",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "LAMOTRIGINE",
  "active_ingred_unit": null,
  "application_number": "ANDA078947",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lamotrigine",
  "start_marketing_date": "20090127",
  "active_numerator_strength": null
}

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