Lacosamide

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN03AX18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
8280499100
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-00)
ndc11
8280499111
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-11)
ndc11
8280499130
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-30)
ndc11
8280499155
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-55)
ndc11
8280499160
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-60)
ndc11
8280499164
240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-64)
ndc11
8280499172
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-72)
ndc11
8280499178
180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-78)
ndc11
8280499190
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-991-90)

Annotations

UNII (FDA Substance ID)

563KS2PQY5

LACOSAMIDE

RxCUI 623400

Orange Book

A205237

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": "82804-991_47ae2f1f-d135-4f4e-acc2-500c1afa7b8b",
  "productndc": "82804-991",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205237",
    "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": "ANDA205237",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20230710",
  "active_numerator_strength": "100"
}

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