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United States · US · US:0078-1077_026e2548-8de0-4776-9802-dd3fff2c2635

VOTRIENT

Orange BookUNIISPLATC L01EX03

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeL01EX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078107766
    120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66)

Annotations

UNII (FDA Substance ID)
33Y9ANM545
PAZOPANIB HYDROCHLORIDE
RxCUI 732187
Orange Book
N022465
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "33Y9ANM545",
    "rxcui": "732187",
    "inchikey": "MQHIQUBXFFAOMK-UHFFFAOYSA-N",
    "display_name": "PAZOPANIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7": {
      "match": "brand_token",
      "title": "VOTRIENT (PAZOPANIB HYDROCHLORIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "15",
      "published_date": "2025-12-17"
    }
  },
  "productid": "0078-1077_026e2548-8de0-4776-9802-dd3fff2c2635",
  "productndc": "0078-1077",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022465",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Oct 19, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Oct 19, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAZOPANIB HYDROCHLORIDE",
  "proprietary_name": "VOTRIENT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022465",
  "marketing_category": "NDA",
  "nonproprietary_name": "pazopanib hydrochloride",
  "start_marketing_date": "20160712",
  "active_numerator_strength": "200"
}

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