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United States · US · US:29300-367_d452fee5-4940-4740-8c4d-8024788eafc6
Lacosamide
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc112930036705500 TABLET, FILM COATED in 1 BOTTLE (29300-367-05)
- ndc11293003671660 TABLET, FILM COATED in 1 BOTTLE (29300-367-16)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A213109
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": "29300-367_d452fee5-4940-4740-8c4d-8024788eafc6",
"productndc": "29300-367",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213109",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Sep 4, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Sep 4, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Sep 4, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "200MG",
"product_no": "004",
"approval_date": "Sep 4, 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": "ANDA213109",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20241201",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AX18.
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