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United States · US · US:72205-034_4e47a51d-1af3-4e8d-b45b-0c1c3ca0f4d0

Lacosamide

Orange BookUNIISPLATC N03AX18

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7220503450
    1 TRAY in 1 BOX (72205-034-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (72205-034-44)
  • ndc11
    7220503474
    200 mL in 1 BOTTLE, PLASTIC (72205-034-74)
  • ndc11
    7220503475
    465 mL in 1 BOTTLE, PLASTIC (72205-034-75)
  • ndc11
    7220503491
    1 TRAY in 1 BOX (72205-034-91) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (72205-034-45)
  • ndc11
    7220503493
    1 TRAY in 1 BOX (72205-034-93) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (72205-034-46)
  • ndc11
    7220503494
    1 TRAY in 1 BOX (72205-034-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE (72205-034-47)

Annotations

UNII (FDA Substance ID)
563KS2PQY5
LACOSAMIDE
RxCUI 623400
Orange Book
A215379
AA
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": "72205-034_4e47a51d-1af3-4e8d-b45b-0c1c3ca0f4d0",
  "productndc": "72205-034",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "215379",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Dec 22, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LACOSAMIDE",
  "proprietary_name": "Lacosamide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215379",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lacosamide",
  "start_marketing_date": "20231222",
  "active_numerator_strength": "10"
}

Related drugs

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