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United States · US · US:69102-359_14718eaf-e725-48ef-b2f8-1bd20b3a7cba
LAMOTRIGINE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOWP Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11691023591114 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-359-11) / 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": "69102-359_14718eaf-e725-48ef-b2f8-1bd20b3a7cba",
"productndc": "69102-359",
"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": "20170830",
"active_numerator_strength": null
}Access this data programmatically
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