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United States · US · US:72266-242_1ddb7a71-0e47-2c7a-e063-6394a90a98b1

Lacosamide

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerFosun Pharma USA
CountryUS (United States)
ATC codeN03AX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7226624205
    5 VIAL, SINGLE-DOSE in 1 CARTON (72266-242-05) / 20 mL in 1 VIAL, SINGLE-DOSE (72266-242-01)

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A215628
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": "72266-242_1ddb7a71-0e47-2c7a-e063-6394a90a98b1",
  "productndc": "72266-242",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215628",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/20ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 19, 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": "ANDA215628",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20221115",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N03AX18.

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