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United States · US · US:67877-732_c4d07291-0152-4092-a339-3edee132ef09

Lacosamide Oral Solution

Orange BookUNIISPLATC N03AX18

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6787773295
    200 mL in 1 BOTTLE (67877-732-95)
  • ndc11
    6787773297
    465 mL in 1 BOTTLE (67877-732-97)

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A214672
AA
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": "67877-732_c4d07291-0152-4092-a339-3edee132ef09",
  "productndc": "67877-732",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214672",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "May 19, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACOSAMIDE",
  "proprietary_name": "Lacosamide Oral Solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214672",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide Oral Solution",
  "start_marketing_date": "20220520",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N03AX18.

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