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United States · US · US:69367-352_89a391c2-4a46-47bc-976a-989442b47c56
Lacosamide
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWestminster Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11693673521010 VIAL, GLASS in 1 CARTON (69367-352-10) / 20 mL in 1 VIAL, GLASS (69367-352-20)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A218706
AP
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": "INTRAVENOUS",
"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": "69367-352_89a391c2-4a46-47bc-976a-989442b47c56",
"productndc": "69367-352",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218706",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/20ML (10MG/ML)",
"product_no": "001",
"approval_date": "May 23, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218706",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20250523",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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