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United States · US · US:82983-427_9fd5f392-f470-4f19-96da-582fae4da496
Lacosamide Oral Solution
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjenat Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118298342731200 mL in 1 BOTTLE, PLASTIC (82983-427-31)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A219699
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": "82983-427_9fd5f392-f470-4f19-96da-582fae4da496",
"productndc": "82983-427",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219699",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Jun 26, 2025"
}
],
"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": "ANDA219699",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20250714",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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