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United States · US · US:72865-235_f3394cab-e834-326c-e053-2a95a90af10e
LACOSAMIDE
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11728652351010 VIAL, GLASS in 1 CARTON (72865-235-10) / 20 mL in 1 VIAL, GLASS (72865-235-01)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A216335
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": "72865-235_f3394cab-e834-326c-e053-2a95a90af10e",
"productndc": "72865-235",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216335",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/20ML (10MG/ML)",
"product_no": "001",
"approval_date": "Sep 14, 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": "ANDA216335",
"marketing_category": "ANDA",
"nonproprietary_name": "LACOSAMIDE",
"start_marketing_date": "20230125",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX18.
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