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United States · US · US:68999-885_4ba97913-d84d-a2c3-e063-6394a90a2363

Lacosamide Oral Solution

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.
CountryUS (United States)
ATC codeN03AX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6899988523
    2 TRAY in 1 BOX (68999-885-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-885-10)
  • ndc11
    6899988524
    2 TRAY in 1 BOX (68999-885-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-885-05)

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A215154
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": "68999-885_4ba97913-d84d-a2c3-e063-6394a90a2363",
  "productndc": "68999-885",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "215154",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "May 15, 2024"
      }
    ],
    "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": "ANDA215154",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20240515",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N03AX18.

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