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United States · US · US:67877-733_062a789f-52f0-482b-9ec0-2ba3ac1572ec

Lacosamide

Orange BookUNIISPLATC N03AX18

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

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
    6787773305
    500 TABLET, FILM COATED in 1 BOTTLE (67877-733-05)
  • ndc11
    6787773331
    6 BLISTER PACK in 1 CARTON (67877-733-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6787773360
    60 TABLET, FILM COATED in 1 BOTTLE (67877-733-60)
  • ndc11
    6787773390
    90 TABLET, FILM COATED in 1 BOTTLE (67877-733-90)

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": "67877-733_062a789f-52f0-482b-9ec0-2ba3ac1572ec",
  "productndc": "67877-733",
  "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": "50"
}

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