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United States · US · US:72205-220_b63d4a4a-6d25-4a28-b870-430043ed6c1b

Lacosamide

Orange BookUNIISPLATC N03AX18

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

Identification

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

Packs · 1

  • ndc11
    7220522007
    10 VIAL in 1 CARTON (72205-220-07) / 20 mL in 1 VIAL (72205-220-01)

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A215979
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": "72205-220_b63d4a4a-6d25-4a28-b870-430043ed6c1b",
  "productndc": "72205-220",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215979",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/20ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 9, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACOSAMIDE",
  "proprietary_name": "Lacosamide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215979",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20230209",
  "active_numerator_strength": "10"
}

Related drugs

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