lacosamide

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerMSN LABORATORIES PRIVATE LIMITED

CountryUS (United States)

ATC codeN03AX18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6953902505
500 TABLET, FILM COATED in 1 BOTTLE (69539-025-05)
ndc11
6953902560
60 TABLET, FILM COATED in 1 BOTTLE (69539-025-60)

Annotations

UNII (FDA Substance ID)

563KS2PQY5

LACOSAMIDE

RxCUI 623400

Orange Book

A204921

ABABABAB

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": "69539-025_421cfdea-11a0-4fd7-8b8f-79711f1e5f89",
  "productndc": "69539-025",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204921",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Mar 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Mar 17, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Mar 17, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACOSAMIDE",
  "proprietary_name": "lacosamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204921",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lacosamide",
  "start_marketing_date": "20220319",
  "active_numerator_strength": "50"
}

Related drugs

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