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United States · US · US:13668-735_6b6119a9-55d1-4a4d-a0aa-d287024a9ed8

pazopanib

Orange BookUNIISPLATC L01EX03

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

Identification

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

Packs · 3

  • ndc11
    1366873530
    30 TABLET, FILM COATED in 1 BOTTLE (13668-735-30)
  • ndc11
    1366873560
    60 TABLET, FILM COATED in 1 BOTTLE (13668-735-60)
  • ndc11
    1366873590
    90 TABLET, FILM COATED in 1 BOTTLE (13668-735-90)

Annotations

UNII (FDA Substance ID)
33Y9ANM545
PAZOPANIB HYDROCHLORIDE
RxCUI 732187
Orange Book
A219922
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": "13668-735_6b6119a9-55d1-4a4d-a0aa-d287024a9ed8",
  "productndc": "13668-735",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "219922",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 400MG BASE",
        "product_no": "001",
        "approval_date": "Sep 4, 2025"
      }
    ],
    "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": "ANDA219922",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pazopanib hydrochloride",
  "start_marketing_date": "20250904",
  "active_numerator_strength": "400"
}

Related drugs

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