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United States · US · US:73289-0063_3a10a8ff-87ff-a36b-e063-6394a90a473c
MOTPOLY XR
Orange BookUNIISPLATC N03AX18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAucta Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1173289006311 BLISTER PACK in 1 CARTON (73289-0063-1) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11732890063260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0063-2)
Annotations
UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
N216185
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": {
"fb8235b4-4cd3-6f22-e053-6294a90a545c": {
"match": "brand_token",
"title": "MOTPOLY XR (LACOSAMIDE) CAPSULE, EXTENDED RELEASE [AUCTA PHARMACEUTICALS, INC.]",
"spl_version": "5",
"published_date": "2025-07-18"
}
},
"productid": "73289-0063_3a10a8ff-87ff-a36b-e063-6394a90a473c",
"productndc": "73289-0063",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "216185",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100MG",
"product_no": "001",
"approval_date": "May 4, 2023"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "150MG",
"product_no": "002",
"approval_date": "May 4, 2023"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG",
"product_no": "003",
"approval_date": "May 4, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": "CV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACOSAMIDE",
"proprietary_name": "MOTPOLY XR",
"active_ingred_unit": "mg/1",
"application_number": "NDA216185",
"marketing_category": "NDA",
"nonproprietary_name": "lacosamide",
"start_marketing_date": "20230505",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AX18.
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