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United States · US · US:83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99
Lacosamide
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSintetica US LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11830900121010 VIAL, GLASS in 1 CARTON (83090-012-10) / 20 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A217311
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": "83090-012_d122b8ed-0688-4516-92a2-4b1fa1e7fa99",
"productndc": "83090-012",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "217311",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/20ML (10MG/ML)",
"product_no": "001",
"approval_date": "Feb 13, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217311",
"marketing_category": "ANDA",
"nonproprietary_name": "lacosamide",
"start_marketing_date": "20240315",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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