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United States · US · US:60505-4779_13431d63-13a5-2a76-c6de-06799bc59e29

Pazopanib

Orange BookUNIISPLATC L01EX03

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeL01EX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6050547795
    500 TABLET in 1 BOTTLE (60505-4779-5)
  • ndc11
    6050547797
    120 TABLET in 1 BOTTLE (60505-4779-7)

Annotations

UNII (FDA Substance ID)
7RN5DR86CK
PAZOPANIB
RxCUI 714438
Orange Book
A217713
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7RN5DR86CK",
    "rxcui": "714438",
    "inchikey": "CUIHSIWYWATEQL-UHFFFAOYSA-N",
    "display_name": "PAZOPANIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5": {
      "match": "brand_token",
      "title": "PAZOPANIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "60505-4779_13431d63-13a5-2a76-c6de-06799bc59e29",
  "productndc": "60505-4779",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217713",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Oct 19, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAZOPANIB",
  "proprietary_name": "Pazopanib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217713",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pazopanib",
  "start_marketing_date": "20231019",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code L01EX03.

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