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United States · US · US:70710-1886_c2dded9d-fd0c-4ddf-b7af-706fed0857d9

LACOSAMIDE

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN03AX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7071018866
    10 VIAL in 1 CARTON (70710-1886-6) / 20 mL in 1 VIAL (70710-1886-1)

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A209465
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": "70710-1886_c2dded9d-fd0c-4ddf-b7af-706fed0857d9",
  "productndc": "70710-1886",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209465",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/20ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 29, 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": "ANDA209465",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20221110",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N03AX18.

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