MOTPOLY XR

Orange BookUNIISPLATC N03AX18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAucta Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN03AX18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7328900652
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (73289-0065-2)

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": "73289-0065_3a10a8ff-87ff-a36b-e063-6394a90a473c",
  "productndc": "73289-0065",
  "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": "200"
}

Related drugs

Other records sharing ATC code N03AX18.

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