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United States · US · US:71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f

Lacosamide Oral Solution

Orange BookUNIISPLATC N03AX18

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

Identification

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

Packs · 1

  • ndc11
    7192141171
    1 BOTTLE in 1 CARTON (71921-411-71) / 200 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A220386
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": "71921-411_ceee316d-6ad9-4bca-9416-47ae954d174f",
  "productndc": "71921-411",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "220386",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jan 29, 2026"
      }
    ],
    "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": "ANDA220386",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide Oral",
  "start_marketing_date": "20260130",
  "active_numerator_strength": "10"
}

Related drugs

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