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United States · US · US:59651-582_25575cc6-5757-4f9b-9c09-0c4deb61ba12

Pazopanib

Orange BookUNIISPLATC L01EX03

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeL01EX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5965158208
    120 TABLET, FILM COATED in 1 BOTTLE (59651-582-08)
  • ndc11
    5965158230
    30 TABLET, FILM COATED in 1 BOTTLE (59651-582-30)
  • ndc11
    5965158290
    90 TABLET, FILM COATED in 1 BOTTLE (59651-582-90)

Annotations

UNII (FDA Substance ID)
33Y9ANM545
PAZOPANIB HYDROCHLORIDE
RxCUI 732187
Orange Book
A219034
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": {
    "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": "59651-582_25575cc6-5757-4f9b-9c09-0c4deb61ba12",
  "productndc": "59651-582",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219034",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Dec 4, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAZOPANIB HYDROCHLORIDE",
  "proprietary_name": "Pazopanib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219034",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pazopanib",
  "start_marketing_date": "20241204",
  "active_numerator_strength": "200"
}

Related drugs

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