Lacosamide

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeN03AX18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787773505
500 TABLET, FILM COATED in 1 BOTTLE (67877-735-05)
ndc11
6787773531
6 BLISTER PACK in 1 CARTON (67877-735-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6787773560
60 TABLET, FILM COATED in 1 BOTTLE (67877-735-60)
ndc11
6787773590
90 TABLET, FILM COATED in 1 BOTTLE (67877-735-90)

Annotations

UNII (FDA Substance ID)

563KS2PQY5

LACOSAMIDE

RxCUI 623400

Orange Book

A214695

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": "67877-735_062a789f-52f0-482b-9ec0-2ba3ac1572ec",
  "productndc": "67877-735",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214695",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Mar 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Mar 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Mar 31, 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": "ANDA214695",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20220401",
  "active_numerator_strength": "150"
}

Related drugs

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