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United States · US · US:71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f
Lacosamide Oral Solution
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171921411711 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A220386
AA
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": "71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f",
"productndc": "71921-411",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "220386",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Jan 29, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide Oral Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA220386",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide Oral",
"start_marketing_date": "20260130",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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