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United States · US · US:43068-585_ca9e3433-499f-4519-bc3a-2d78302ee6a0

NEREUS

Orange BookUNIISPL

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

Identification

ManufacturerVanda Pharmaceuticals Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4306858501
    60 CARTON in 1 BOTTLE (43068-585-01) / 1 CAPSULE in 1 CARTON
  • ndc11
    4306858502
    36 CARTON in 1 BOTTLE (43068-585-02) / 1 CAPSULE in 1 CARTON

Annotations

UNII (FDA Substance ID)
NY0COC51FI
TRADIPITANT
Orange Book
N220152
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NY0COC51FI",
    "rxcui": null,
    "inchikey": "CAVRKWRKTNINFF-UHFFFAOYSA-N",
    "display_name": "TRADIPITANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1a021ebd-16ac-4354-b4b2-1c3950c091e5": {
      "match": "brand_token",
      "title": "NEREUS (TRADIPITANT) CAPSULE [VANDA PHARMACEUTICALS INC.]",
      "spl_version": "3",
      "published_date": "2026-04-02"
    }
  },
  "productid": "43068-585_ca9e3433-499f-4519-bc3a-2d78302ee6a0",
  "productndc": "43068-585",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "220152",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "85MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRADIPITANT",
  "proprietary_name": "NEREUS",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA220152",
  "marketing_category": "NDA",
  "nonproprietary_name": "TRADIPITANT",
  "start_marketing_date": "20260331",
  "active_numerator_strength": "85"
}

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