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United States · US · US:72205-055_403b6540-c53d-4e92-91b4-36ca6338b2b1

pimavanserin

Orange BookUNIISPLATC N05AX17

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeN05AX17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
NA83F1SJSR
PIMAVANSERIN TARTRATE
RxCUI 1791686
Orange Book
A214925
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NA83F1SJSR",
    "rxcui": "1791686",
    "inchikey": "RGSULKHNAKTFIZ-CEAXSRTFSA-N",
    "display_name": "PIMAVANSERIN TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "403b6540-c53d-4e92-91b4-36ca6338b2b1": {
      "match": "brand_token",
      "title": "PIMAVANSERIN CAPSULE [NOVADOZ PHARMACEUTICALS LLC]",
      "spl_version": "1",
      "published_date": "2025-12-23"
    }
  },
  "productid": "72205-055_403b6540-c53d-4e92-91b4-36ca6338b2b1",
  "productndc": "72205-055",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214925",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 34MG BASE",
        "product_no": "001",
        "approval_date": "Jan 16, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PIMAVANSERIN TARTRATE",
  "proprietary_name": "pimavanserin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214925",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pimavanserin",
  "start_marketing_date": "20240116",
  "active_numerator_strength": "34"
}

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