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United States · US · US:33342-305_035d85e5-8688-4390-bd55-74baa91c0e9d
Lacosamide
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11333423050960 TABLET, FILM COATED in 1 BOTTLE (33342-305-09)
- ndc113334230511100 TABLET, FILM COATED in 1 BOTTLE (33342-305-11)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A208466
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "563KS2PQY5",
"rxcui": "623400",
"inchikey": "VPPJLAIAVCUEMN-GFCCVEGCSA-N",
"display_name": "LACOSAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cd5ac33e-6ac5-772b-2ead-d66cbd5bd1b4": {
"match": "brand_token",
"title": "LACOSAMIDE INJECTION [DR. REDDY'S LABORATORIES INC.]",
"spl_version": "8",
"published_date": "2026-05-28"
}
},
"productid": "33342-305_035d85e5-8688-4390-bd55-74baa91c0e9d",
"productndc": "33342-305",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208466",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "May 24, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "May 24, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "May 24, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "May 24, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208466",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20240524",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AX18.
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