Torisel

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0008117901
1 KIT in 1 CARTON (0008-1179-01) * 25 mL in 1 VIAL, SINGLE-USE (0008-1279-01) * 1.8 mL in 1 VIAL, SINGLE-USE (0008-1125-01)

Annotations

Orange Book

N022088

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "95b7dc92-2180-42f1-8699-3c28f609e674": {
      "match": "brand_token",
      "title": "TORISEL (TEMSIROLIMUS) KIT [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "39",
      "published_date": "2025-12-29"
    }
  },
  "productid": "0008-1179_8731b3b1-29d9-46b1-a443-822d8057f773",
  "productndc": "0008-1179",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022088",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/ML (25MG/ML)",
        "product_no": "001",
        "approval_date": "May 30, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Torisel",
  "active_ingred_unit": null,
  "application_number": "NDA022088",
  "marketing_category": "NDA",
  "nonproprietary_name": "temsirolimus",
  "start_marketing_date": "20070701",
  "active_numerator_strength": null
}

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