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United States · US · US:68083-480_784837da-eb6c-43e1-87ea-367e2d07cd1c
Lacosamide
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680834801010 VIAL, SINGLE-DOSE in 1 CARTON (68083-480-10) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A215628
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": "68083-480_784837da-eb6c-43e1-87ea-367e2d07cd1c",
"productndc": "68083-480",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215628",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/20ML (10MG/ML)",
"product_no": "001",
"approval_date": "Sep 19, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "Lacosamide",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215628",
"marketing_category": "ANDA",
"nonproprietary_name": "Lacosamide",
"start_marketing_date": "20220919",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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