Lacosamide Oral Solution

Orange BookUNIISPLATC N03AX18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKesin Pharmaceutical Corporation

CountryUS (United States)

ATC codeN03AX18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8103342714
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-14) / 5 mL in 1 CUP, UNIT-DOSE (81033-427-05)
ndc11
8103342716
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-16) / 10 mL in 1 CUP, UNIT-DOSE (81033-427-10)
ndc11
8103342717
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-17) / 15 mL in 1 CUP, UNIT-DOSE (81033-427-15)
ndc11
8103342718
10 CUP, UNIT-DOSE in 1 CARTON (81033-427-18) / 20 mL in 1 CUP, UNIT-DOSE (81033-427-20)

Annotations

UNII (FDA Substance ID)

563KS2PQY5

LACOSAMIDE

RxCUI 623400

Orange Book

A219699

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": "81033-427_3ba29442-4e8b-c2b2-e063-6294a90a1bbf",
  "productndc": "81033-427",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "219699",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jun 26, 2025"
      }
    ],
    "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": "ANDA219699",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20250805",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N03AX18.

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